Hemostasis valve and delivery systems

ABSTRACT

A hemostasis valve includes a longitudinal valve housing, a gasket, a grip assembly and an interference element. A x-valve includes a valve housing, at least one sealing component and a support layer. Stent graft delivery systems include a handle, an internal lead screw assembly, a lead screw nut, a support member fixed to the handle body, a sheath and a hemostasis valve.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.13/834,808, filed Mar. 15, 2013, now U.S. Pat. No. 9,439,751. The entireteachings of the above application are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Stent graft delivery systems have been designed to treat abdominalaortic aneurysms (AAA). Successful placement of components of aprosthesis is critical to bypass the aneurysm. Prostheses can bedeployed as multiple units, each requiring separate deployment from adelivery system. Prevention of extracorporeal blood flow while changingdelivery devices during implantation of a main prosthesis, or in theabsence of blood vessel filling catheters or accessories, can beaccomplished by hemostasis valves. Thus, there is a need to develop new,useful and effective delivery systems, components and methods havinghemostasis valves to treat AAA.

SUMMARY OF THE INVENTION

The present invention relates to delivery systems, components ofdelivery systems and methods of using the delivery systems and itscomponents to treat vascular damage, in particular AAA.

In one embodiment, the invention is a hemostasis valve that includes alongitudinal valve housing, a gasket housing, a grip assembly at theproximal end of the longitudinal valve housing, and interference elementat the longitudinal valve housing. The longitudinal valve housingdefines a conduit and has a proximal end and a distal end. The gasketwithin the housing defines an interior conduit and has a distal end, thedistal end being fixed relative to the longitudinal valve housing, aproximal end moveable relative to the longitudinal valve housing, and acollapsible intermediate portion between the distal end and the proximalend. In an embodiment, the interior conduit of the gasket has anessentially constant diameter from the distal end portion to theproximal end portion of the gasket. The grip assembly at the proximalend of the longitudinal valve housing is linked to the proximal end ofthe gasket. The grip assembly includes: a grip portion at the first endof, and rotatable relative to, the longitudinal valve housing; a spindleportion extending from the grip portion and within the conduit of thelongitudinal valve housing, the spindle being fixed to the gasket at theproximal end of the gasket; and a ratchet extending about the spindleand fixed to the spindle. The ratchet defines teeth and is at the end ofthe ratchet extending about the spindle. The ratchet is biased in adirection relative to the longitudinal valve housing and along the majorlongitudinal axis of the longitudinal valve housing. The interferenceelement is located within the longitudinal valve housing, is ininterfering relation with the teeth of the ratchet, and is biasedagainst the teeth of the ratchet, whereby rotation of the grip portionrelative to the longitudinal valve housing causes rotation of theproximal end of the gasket relative to the distal end of the gasket,thereby changing the internal diameter of the internal conduit. Rotationof the grip portion relative to the housing also causes the teeth of theratchet to disengage and reengage the interference element with theratchet, re-engagement of the ratchet with interference element lockingthe diameter of the internal conduit of the gasket in place upontermination of rotation of the grip portion relative to the longitudinalvalve housing.

Another embodiment of the invention is an x-valve that includes: a valvehousing; at least one sealing component within the valve housing,wherein the sealing component defines at least one slot; and a supportlayer at least partially embedded within the sealing component.

In still another embodiment of the invention, a stent graft deliverysystem of the invention includes: a handle; an internal lead screwassembly; a lead screw nut; a support member: a sheath extending about aportion of the support member; and a hemostasis valve about thesupporting member. The handle includes a distal grip and a handle bodyextending from one end of the distal grip. The handle body defines aconduit and a track along a portion of the length of the distal grip andthe handle body. The internal lead screw assembly is located within thetrack, is movable along a major axis of the conduit, and includes athreaded portion that extends through the track. The lead screw nutextends about the handle body and is threadably engaged with thethreaded portion of the internal lead screw assembly, whereby rotationof the lead screw nut while abutting the distal grip causes movement ofthe internal lead screw assembly relative to the handle. The lead screwnut is simultaneously slidable along the handle body while engaged withthe internal lead screw assembly, thereby providing at least twomechanisms for causing movement of the internal lead screw relative tothe handle. The support member is fixed to the handle body and thesheath extending about a portion of the support member is fixed to theinternal screw assembly, whereby relative movement of the handle bodyand the lead screw assembly causes relative movement of the supportmember and sheath, wherein the support member includes a hypo tube and asupport tube within the hypotube, wherein the hypotube is fixed to thehandle body, and wherein the internal lead screw assembly defines anopening essentially coaxial with the handle, wherein the support memberextends through the internal lead screw assembly. The hemostasis valveextends about the support member and between the sheath and the internallead screw assembly, wherein the hemostasis valve includes a gaskethaving a distal end and a proximal end along a major longitudinal axisof the delivery system, and defines an internal conduit between thedistal end of the gasket and a proximal end of the gasket through whichthe support member extends, wherein actuation of the hemostasis valvenarrows the internal conduit about the support member, thereby closingthe hemostasis valve.

In one embodiment of the stent graft delivery system of the invention,the hemostasis valve includes an x-valve along a longitudinal axis ofthe delivery system, wherein the x-valve includes at least one pair ofsealing layers defining intersecting slots and a support layerpartitioning the sealing layers.

The hemostasis valves of the invention have the advantage of providingselective and secure complete opening and closing of blood flow whilechanging delivery devices to implantation components of prosthesis totreat AAA. Thus, delivery systems, components of delivery systems andmethods of the invention can be used to treat AAA and, therefore, avoidcomplications and death consequent to life threatening vascularconditions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 represents an embodiment of a delivery system of the invention.

FIG. 2 represents an embodiment of a delivery system of the invention.

FIG. 3 represents an embodiment of a delivery system of the invention.

FIG. 4 depicts an embodiment of a stent delivery system of theinvention.

FIG. 5 depicts an embodiment of a stent delivery system of theinvention.

FIG. 6 depicts an embodiment of a stent delivery system of theinvention.

FIG. 7 is an alternative embodiment of the delivery system of theinvention.

FIG. 8 is an alternative embodiment of the delivery system of theinvention.

FIG. 9 is an alternative embodiment of the delivery system of theinvention.

FIG. 10 is an embodiment for connecting an outer sheath handle to aninner screw that can be employed in the delivery systems of theinvention. Screws (716) are offset to fall in the threads.

FIG. 11 is an embodiment for connecting an outer sheath handle to aninner screw that can be employed in the delivery systems of theinvention.

FIG. 12 is an embodiment of the delivery system of the invention. Thehandle is turned (curved arrow) to retract sheath. Handle is heldstationary while turning the handle to retract the sheath.

FIG. 13 is an embodiment of the delivery system of the invention. Whenthreads are completely disengaged, the handle will lock into the slotsand the bore spring and sealing spring will be exposed.

FIG. 14 is an embodiment of the delivery system of the invention. Thesheath is retracted so the main body of the bifurcated graft is exposedby sliding the handle over the threaded engagement.

FIGS. 15A, 15B, 15C and 15 D are embodiments of the delivery system ofthe invention. As shown in FIG. 15A, the apex clasp is released todeliver the bifurcated stent graft. The arrow depicts force.

FIG. 16 is another embodiment of the delivery system of the invention.

FIG. 17 is another embodiment of the delivery system of the invention.

FIG. 18 is another embodiment of the delivery system of the invention.

FIG. 19 is another embodiment of the delivery system of the invention.

FIG. 20 is another embodiment of the delivery system of the invention.The handle is turned (curved arrow) to retract the sheath. The handle iskept stationary while turning to retract the sheath.

FIG. 21 is another embodiment of the delivery system of the invention.Once the threads are completely disengaged the bare spring and sealingspring will be exposed and the turning of the handle will not retractthe sheath back any further.

FIG. 22 is another embodiment of the delivery system of the invention.Pin and pull—retract the sheath so the main body of the graft is exposedby sliding the handle back over the lead screw handle.

FIG. 23 is another embodiment of the delivery system of the invention.The apex clasp is released.

FIG. 24 is another embodiment of the delivery system of the invention.

FIG. 25 is another embodiment of the delivery system of the invention.

FIG. 26 is another embodiment of the delivery system of the invention.

FIG. 27 is another embodiment of the delivery system of the invention.

FIG. 28 is another embodiment of the delivery system of the invention.

FIG. 29 is another embodiment of the delivery system of the invention.Arrow indicates a distal end of an inner support member.

FIG. 30 is another embodiment of the delivery system of the invention.Arrow indicates proximal end of an inner support member.

FIG. 31 is another embodiment of the delivery system of the invention.Arrow indicates component to attach internal tube to distal handle grip.

FIG. 32 is another embodiment of the delivery system of the invention.Arrow indicates stop position indicator in locked position.

FIG. 33 is a further embodiment of the delivery system of the invention.

FIG. 34 is a further embodiment of the delivery system of the invention.Arrow indicates a side view of a lead screw.

FIG. 35 is a further embodiment of the delivery system of the invention.Arrow indicates an end view of a lead screw.

FIG. 36 is a further embodiment of the delivery system of the invention.Arrow indicates a lead screw rail.

FIG. 37 is a further embodiment of the delivery system of the invention.

FIG. 38 is a further embodiment of the delivery system of the invention.

FIG. 39 is a further embodiment of the delivery system of the invention.

FIG. 40 is a further embodiment of the delivery system of the inventionthat includes a distal clasp assembly (ASSY) and a loading mandrel(manufacture (MFG) aid).

FIG. 41 is a further embodiment of the delivery system of the invention.

FIG. 42 is a further embodiment of the delivery system of the invention.

FIG. 43 is a further embodiment of the delivery system of the invention.

FIG. 44 is a further embodiment of the delivery system of the invention.

FIG. 45 is a further embodiment of the delivery system of the invention.

FIG. 46 is a further embodiment of the delivery system of the invention.

FIG. 47 is a further embodiment of the delivery system of the invention.

FIG. 48 is a further embodiment of the delivery system of the invention.

FIG. 49 is a further embodiment of the delivery system of the invention.

FIG. 50 is a further embodiment of the delivery system of the invention.

FIG. 51 is a further embodiment of the delivery system of the invention.

FIG. 52 is a lead screw embodiment of the invention.

FIG. 53 is a lead screw embodiment of the invention.

FIG. 54 is a lead screw embodiment of the invention.

FIGS. 55A and 55B are additional embodiments of the delivery system ofthe invention.

FIG. 56 is another embodiment of the delivery system of the invention.

FIGS. 57A, 57B, 57C, 57D, 57E and 57F are another embodiment of thedelivery system of the invention (sheath valve assembly).

FIG. 58 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 59 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 60 is an embodiment of a distal tip of the delivery system of theinvention.

FIG. 61 is an embodiment of a delivery system of the invention.

FIG. 62 is an embodiment of a delivery system of the invention.

FIG. 63 is an embodiment of a delivery system of the invention.

FIGS. 64A and 64B are embodiments of a delivery system of the invention.

FIG. 65 is an additional embodiment of the delivery system of theinvention. An exemplary length of the sheath can be 84 cm.

FIG. 66 is an additional embodiment of the delivery system of theinvention that includes a tip assembly (ASSY), support member assembly(ASSY) and a guidewire (GW) hypo-tube.

FIG. 67 is an additional embodiment of the delivery system of theinvention that employs, for example, stainless steel and nylon.

FIG. 68 is an additional embodiment of the delivery system of theinvention.

FIG. 69 is an additional embodiment of the delivery system of theinvention.

FIGS. 70A, 70B and 70C are embodiments of a leg clasp system of theinvention.

FIG. 71 is a representation of an abdominal aortic aneurysm.

FIGS. 72A, 72B and 72C are embodiments of a stent graft system of theinvention. FIG. 72A is an example of placement of a stent graft systemof the invention to treat an abdominal aortic aneurysm.

FIG. 73 is an embodiment of a stent of the invention.

FIG. 74 is an embodiment of a stent of the invention.

FIG. 75 is an embodiment of a stent of the invention.

FIGS. 76A and 76B are embodiments of a component of a delivery system ofthe invention.

FIG. 77 is an embodiment of an eyelet of a stent of the invention.

FIGS. 78A, 78B and 78C are embodiments of a telescoping stent graftssystem of the invention.

FIGS. 79A, 79B and 79C are embodiments of a telescoping stent graftssystem of the invention.

FIG. 80 is an embodiment of a stent of the invention.

FIG. 81 is a representation of an unexpanded stent of the invention.

FIG. 82 is a representation of an unexpanded stent of the invention.

FIG. 83 is a representation of an unexpanded stent of the invention.

FIG. 84 is a representation of an unexpanded stent of the invention.

FIG. 85 is a representation of an unexpanded stent of the invention.

FIGS. 86A, 86B, 86C, 86 D and 86E are an embodiment of the apex capturedevice of the invention.

FIGS. 87A and 87B are embodiments of the apex capture device of theinvention.

FIGS. 88A and 88B are embodiments of the apex capture device of theinvention.

FIG. 89 is an embodiment of multiple stents of the invention.

FIG. 90 is an embodiment of multiple stents of the invention.

FIG. 91 is an embodiment of multiple stents of the invention.

FIG. 92 is an embodiment of multiple stents of the invention.

FIG. 93 is an embodiment of multiple stents of the invention.

FIG. 94 is an embodiment of multiple stents of the invention.

FIG. 95 is a representation of a modular component of a stent-graftsystem of the invention.

FIG. 96 is a representation of a modular component of a stent-graftsystem of the invention.

FIG. 97 is an embodiment of a stented graft of the invention.

FIG. 98 is an embodiment of a stented graft of the invention.

FIG. 99 is an embodiment of a stented graft of the invention.

FIG. 100 is an embodiment of a stented graft of the invention.

FIG. 101 is an embodiment of a stented graft of the invention.

FIG. 102 is an embodiment of a stented graft of the invention.

FIG. 103 is an embodiment of a stent of the invention.

FIG. 104 is an embodiment of a stent of the invention.

FIGS. 105A, 105B and 105C are embodiments of a stent of the invention.

FIG. 106 is an embodiment of a stent of the invention.

FIG. 107 is an embodiment of a barb of the invention.

FIG. 108 is an embodiment of a stent of the invention.

FIG. 109 is an embodiment of a stent graft of the invention.

FIG. 110 is an embodiment of a barb of the invention.

FIG. 111 is an embodiment of a barb of the invention.

FIG. 112 is an embodiment of a stent graft of the invention.

FIG. 113 is an embodiment of a stent graft of the invention.

FIG. 114 is a further embodiment of a component of the delivery systemof the invention.

FIG. 115 is a further embodiment of a component of the delivery systemof the invention.

FIG. 116 is a representation of a stent graft system of the invention asviewed following placement in a mock-silicon aorta.

FIG. 117 is an embodiment of a component of the delivery system of theinvention.

FIG. 118 is an embodiment of a component of the delivery system of theinvention.

FIG. 119 is an embodiment of a component of the delivery system of theinvention.

FIG. 120 is an embodiment of a component of the delivery system of theinvention.

FIG. 121 is an embodiment of a component of the delivery system of theinvention.

FIG. 122 is an embodiment of a component of the delivery system of theinvention.

FIG. 123 is an embodiment of a component of the delivery system of theinvention.

FIG. 124 is an embodiment of a component of the delivery system of theinvention.

FIG. 125 is representative of a leg clasp of the invention.

FIG. 126 is representative of a leg clasp of the invention.

FIGS. 127A, 127B, 127C and 127D are representative of a telescopingstent graft system of the invention.

FIG. 128 is an embodiment of the delivery system of the invention.

FIG. 129A is a perspective view of a representation of an embodiment ofa hemostasis valve of the invention.

FIG. 129B is a perspective view of a representation of components of anembodiment of a hemostasis valve of FIG. 129A.

FIG. 129C is another perspective view of a representation of embodimentsof x-valves of a hemostasis valve of FIG. 129A.

FIG. 129D is a perspective view of a representation of an embodiment ofan x-valve of a hemostasis valve of FIG. 129A.

FIG. 130 is a perspective view of a representation of an embodiment of aspindle, proximal oetiker clamp, distal oetiker clamp, gasket and mainboss of a hemostasis valve of FIG. 129A.

FIG. 131 A is a partial cutaway of an embodiment of a hemostasis valveof FIG. 129A.

FIG. 131B is another partial cutaway of an embodiment of a hemostasisvalve of FIG. 129A.

FIG. 131C is another partial cutaway of an embodiment of a hemostasisvalve of FIG. 129A.

FIG. 132 A is a detailed perspective view of an x-valve of FIG. 129C.

FIG. 132B is a detailed perspective view of an x-valve of FIG. 129C.

DETAILED DESCRIPTION OF THE INVENTION

The features and other details of the invention, either as steps of theinvention or as combinations of parts of the invention, will now be moreparticularly described and pointed out in the claims. It will beunderstood that the particular embodiments of the invention are shown byway of illustration and not as limitations of the invention. Theprinciple features of this invention can be employed in variousembodiments without departing from the scope of the invention.

In an embodiment, represented by FIGS. 1 through 57, as an example, theinvention is a stent graft delivery system 5500, comprising a handlethat includes distal grip 5530 and handle body 5540 extending from oneend of distal grip 5530, the handle defining conduit and track 5542along a portion of the length of distal grip 5530 and handle body 5540;an internal lead screw assembly 5510 within the conduit, the internallead screw assembly 5510 being moveable along a major axis of theconduit, and including a threaded portion 5512 that extends through thetrack 5542; a lead screw nut 5520 that extends about the handle body5540 and threadably engaged with the threaded portion 5512 of theinternal lead screw assembly 5510, whereby rotation of the lead screwnut 5520 while abutting the distal grip 5530 causes movement of theinternal lead screw assembly 5510 relative to the handle and wherein thelead screw nut 5520 simultaneously is slidable along the handle body5540 while engaged with the internal lead screw assembly 5510, therebyproviding at least two mechanisms for causing movement of the internallead screw assembly 5510 relative to the handle.

Referring to FIG. 57A, the stent graft delivery system can furtherinclude a support member 5740 fixed to the handle body, and an outersheath 5550 extending about a portion of the support member 5740 andfixed, either directly or through slider 5700, to the internal leadscrew assembly 5510, whereby relative movement of the handle body 5540and the internal lead screw assembly 5510 causes relative movement ofthe support member 5740 and the outer sheath 5550.

The internal lead screw assembly 5510 of the stent graft delivery system5500 of the invention can define an opening essentially coaxial with thehandle, wherein the support member extends through the internal leadscrew assembly, as shown in FIG. 55A.

As can be seen in the inset of FIG. 57A, support member 5740 includes ahypo-tube 5742 and a support tube 5744 within the hypo-tube 5742.Hypo-tube 5742 typically is formed of stainless steel, while supporttube 5744 typically is formed of nylon, such as VESTAMID®. Hypo-tube5742 is fixed to the handle body, such as at proximal end cap 5544, asshown in FIG. 56 (also shown as end cap 3350 in FIG. 33). Also shown inthe inset to FIG. 57A, but not part of support member 5740, are elongatemember 8614, which is connected to distal apex capture portion 8610, andlumen 8613, which is connected to proximal apex capture portion 8600 a,all of which are shown in FIG. 86D.

The stent graft delivery system of the invention can further include aslider 5700. The slider 5700 of the stent graft delivery systemcomprises a slider body 5720 defining a central orifice through whichthe support member 5740 extends and a flush valve orifice 5712 extendingsubstantially normal to the central orifice, the slider body 5720 beingdetachably fixable to the internal lead screw assembly 5510 (FIG. 55A bysuitable means, such as, for example, release pin 6210, which extendsthrough internal lead screw assembly into slider, as shown in FIGS. 62and 63); a slider cap 5710 coupled to a distal end of the slider body5720, the slider cap 5710 defining a central orifice that issubstantially aligned with the central orifice of the slider body 5720and through which the support member 5740 extends; a sheath valve knob5790 threadably coupled to slider body 5720, an outer sheath 5550extending from a distal end of the slider cap 5710, the outer sheath5550 defining a lumen that is substantially aligned with the centralopening of the slider body 5720 and through which the support member5740 extends; a wiper valve 5750 at the central opening of the sliderbody proximal to the flush valve orifice 5712, the wiper valve 5750forming a seal about the support member; an x-valve 5760 at the centralopening of the slider body proximal to the wiper valve 5750, the x-valve5760 forming a seal about a guidewire within support tube 5744 uponwithdrawal of the support member from the slider body 5720; and a sheathvalve 5770 at the central opening of the slider body 5720 and proximalto the x-valve 5760, the sheath valve 5770 being operable by activationof knob 5790 to seal the central opening.

In an embodiment, the x-valve 5760 includes a nitinol gasket as shown inFIGS. 57B through 57F.

“Proximal” means, when reference is made to a delivery system or acomponent of a delivery system, such as an apex capture device, a sliderfor a stent graft delivery system or a leg clasp, closest to theclinician using device. Likewise, “distal” means, when reference is madeto a delivery system or a component of a delivery system, such as anapex capture device, a slider for a stent graft delivery system or a legclasp, away from the clinician using the device.

When reference is made to a “stent” or a “stent graft system,”“proximal” means that end of the stent or stent graft system that istowards the heart of the patient and “distal” means that end of thestent or stent graft system that is away from the heart of the patient.

In another embodiment, the invention is a slider 5700 for a stent graftdelivery system, the slider 5700 comprising a slider body 5720 defininga central orifice through which a support member 5740 extends and aflush valve orifice 5712 extending substantially normal to the centralorifice, the slider body 5720 being detachably fixable to an internallead screw assembly 5510 (FIGS. 55 and 56); a slider cap 5710 (FIG. 57A)coupled to a distal end of the slider body, the slider cap 5710 defininga central orifice that is substantially aligned with the central orificeof the slider body 5720 and through which the support member extends; aknob 5790 threadably coupled to slider body 5720, an outer sheath 5550extending from a distal end of the slider cap 5710, the outer sheath5550 defining a lumen that is substantially aligned with the centralopening of the slider body 5720 and through which the support member5740 extends; a wiper valve 5750 at the central opening of the sliderbody 5720 proximal to the flush valve orifice 5712, the wiper valve 5750forming a seal about the support member 5740; an x-valve 5760 at thecentral opening of the slider body 5720 proximal to the wiper valve5750, the x-valve 5760 forming a seal about a guidewire within controltube 5744 upon withdrawal of the support member 5740 from the sliderbody 5720; and a sheath valve 5770 at the central opening of the sliderbody 5720 and proximal to the x-valve 5760, the sheath valve 5770 beingoperable by activation of the knob 5790 to seal the central opening.

FIGS. 61-64B are embodiments of a delivery system of the invention.

Referring now to FIGS. 1 to 3, an exemplary embodiment of an improvedpin-and-pull delivery system 100 according to the present invention isshown. The pin-and-pull delivery system 100 provides an inner lumen orsecondary handle 110 that is slidably disposed within an outer sheathcontrol lumen or outer handle 120. This configuration of the lumens 110,120 can also be referred to as a telescopic assembly. The outer sheathcontrol lumen 120 is longitudinally and rotationally fixed to a sheath130 that is used to house the non-illustrated stent graft.

In an exemplary embodiment, the outer sheath control lumen 120 is analuminum tube attached to a sheath hub 140, which is attached to thesheath 130. The inner lumen 110 is polycarbonate tube having alongitudinally cut slot 310 (e.g., see FIG. 3). The inner lumen 110 islongitudinally and rotationally fixed to a pushrod 150 (e.g., astainless steel hypo-tube). By attaching the outer handle 120 to thesheath hub 140, the secondary handle 110 can be retracted into the outerhandle 120 and will maintain rotational alignment of the handles 110,120 by the presence of a setscrew 320 engaged in the slot 310. Thegroove and set-screw configuration will prevent the sheath 130 fromrotating when the stent graft is deployed, which movement undesirablytwists the prosthesis from a desired implantation position. This deviceis beneficial when used with a detachable sheath because the hemostasis160, over the push rod 150, is in front of the handle mechanism 110,120.

FIGS. 4 to 6 illustrate how the delivery system of FIGS. 1 to 3 can beused to implant a bifurcated stent graft. When the compressed bifurcatedstent graft 410 is positioned at a target site, the delivery system ispinned with respect to the patient. The outer handle 120 is drawnproximally from the position shown in FIG. 4 to the position shown inFIG. 5. With the outer handle 120 in the fully retracted position (FIG.5), the stent graft 410 is almost completely deployed in the patient'svessel. The only remaining control of the stent graft 410 is thereleasable grasping of bare stent apices 412 by the apex capture device510 of the delivery system. Control of the capture device 510 occursfrom the proximal-most end of the pushrod 150. One exemplary embodimentof the apex capture device 510 and its control assembly is disclosed inthe family of applications beginning with U.S. Provisional PatentApplication Ser. No. 60/499,652, filed Sep. 3, 2003, and U.S. patentapplication Ser. No. 10/784,462, filed Feb. 23, 2004, which applicationsand the entire family thereof is hereby incorporated by reference hereinin its entirety. In such an embodiment, a non-illustrated control rodinternal to the pushrod 150 is moved relative (arrow A in FIG. 6) to thepushrod 150 to separate the tines grasping one or more of the exposedbare stent apices 412 from control surfaces. This movement creates a gaptherebetween to free the apices 412 from their controlled capture.

An alternative embodiment to that illustrated in FIGS. 5 and 6 is shownin FIGS. 7 to 9. This handle 700 improves the control and accuracy ofdeployment of the stent graft by adding mechanical advantage to theretraction of the introducer outer sheath. Mechanical advantage allowsfor a “smooth” retraction of the outer sheath by not allowing the buildup of potential energy, stored in the compressed stent graft, to causean unexpected jumping or jerking motion during outer sheath retraction.More specifically, the handle 700 has two interconnecting parts: ahollow outer sheath handle 710 and an inner screw handle 720. Theproximal end of the outer sheath handle 710 has an interior cavity forreceiving therein the distal end of the inner screw handle 720.

One exemplary embodiment for connecting the outer sheath handle 710 tothe inner screw handle 720 is illustrated in FIGS. 10 and 11. A threadengagement portion 712 of the sheath handle 710 has two opposing threadengagement devices 714, 716 longitudinally offset from one another asillustrated in FIG. 10. One of the devices 714 can be, for example, aball screw, and the other device 716 can be a set screw. The innersurface of the outer hollow sheath handle 710 is smooth in thisparticular embodiment. Engagement of the outer sheath handle 710 to thethreads 726 of the inner screw handle 720 is made by having the devices714, 716 ride in the threads of the inner screw handle 720. Thus,turning of the inner screw handle 720 causes the outer sheath handle 710to retract over or extend from the distal end of the inner screw handle720 in a controlled fashion. Turning can be assisted with a proximalturn knob 722 rotationally fixed to the inner screw handle 720.

Threads 726 extends for a longitudinal length that is greater than theamount that is necessary to overcome the greatest force required forstent graft deployment. Once that greatest point of force is overcome,the chance of handle jerk or slippage decreases and, therefore, the twohandle portions 710, 720 can be moved longitudinally freely with respectto one another. To achieve the transition from longitudinal controlledand slow movement to longitudinal free movement (and speedy if desired),at the proximal end of the threads of the inner screw handle 720, screwchannels 724 can be cut into the handle body to allow the threadedengagement device 716 to fall into one of the channels 724 and thethreaded engagement device 714 to fall into the other channel (notillustrated) on the opposite side of the screw handle 720. A threadedengagement device 714 can be, for example, a ball screw, which would bedesirable in this configuration because it can be used to center thethreads against the relatively harder threaded engagement device 716,such as a set screw. Changing the force the devices 714, 716 impartagainst the threads can be accomplished by adjusting the tension on aball of the ball set screw or by decreasing the depth of a set screwinto the handle 710.

Functioning of the handle 700 is illustrated, for example, in thediagrams of FIGS. 12, 13, 14,15A, 15B, 15C and 15D. Before the innerscrew handle 720 is turned to retract the outer sheath handle 710, theouter sheath lumen 1210 completely covers the stent graft 1220, which isloaded therein just behind (proximal of) the nose cone 1230. The turnknob 722 is rotated to move the outer sheath handle 710 proximally andbegin to deploy the stent graft 1220 from the outer sheath lumen 1210.The user holds the inner screw handle 720 longitudinally stationarywhile turning so that the outer sheath lumen 1210 moves proximally. Thisstep is shown in FIG. 13. Once the threads 726 (FIG. 12) are completelydisengaged from the thread engagement portion 712 of the sheath handle710, the outer sheath handle 710 will rotationally lock into thechannels 724 while still being longitudinally free to move with respectto the inner screw handle 720. At this point, the bare stent 1310 andthe first sealing stent 1320 are exposed. After channel lock occurs, theproximal end of the stent graft 1220 is exposed from the outer sheathlumen 1210 as shown in FIG. 13. With the opposing threaded engagementdevices 714, 716 (FIG. 11) locked into the channels 724 (FIG. 12), theouter sheath handle 710 can no longer rotate with respect to the innerscrew handle 720 and, now, can be moved proximally as desired by theuser. Accordingly, the outer sheath lumen 1210 can be retracted so thatthe entire body of the stent graft 1220 is exposed as shown in FIG. 14.At this point, the outer sheath handle 710 is positioned over the innerscrew handle 720 and up to the turn knob 722 and the stent graft 1220 isonly held to the delivery system 700 by the apex clasp device 1410. Withrelease of the apex clasp device 1410, the stent graft 1220 is releasedfrom the delivery system 700 and, thereafter, the delivery system 700can be removed from the patient without impacting the implantation ofthe stent graft 1220.

The delivery system 700 of FIGS. 12, 13, 14, 15A, 15B, 15C and 15D canbe loaded with a 28 mm×150 mm graft into a 19.5 French OD braidedintroducer sheath, for example. In this configuration, the deliverysystem can deploy the bifurcated stent graft 1220 utilizing themechanical advantage applied by the screw mechanism to release the firstsection of the graft (bare stent 1310 and first sealing stent 1320). Theremainder of the stent graft can, then, be deployed by the pin-and-pullassembly of the device after the threads 726 are disengaged. Thisconfiguration eliminates any requirement to have the physician activelydisengage the threads.

Benefits achieved by the telescopic configurations shown in FIGS. 1 to15 are illustrated with regard to FIGS. 15A, 15B,15C and 15D. Thepin-and-pull systems of the prior art experienced an undesired force tothe inner stabilizing member during deployment because there is atendency to flex where gripped thereon (FIGS. 15A, 15B, 15C and 15D).This flexing caused misalignment of the sheath hub and the innerstabilizing member, which, in turn, required the physician to increasedeployment forces for retracting the outer sheath, thus, correspondinglyincreasing the force against the inner stabilizing member (a damagingcycle).

An alternative to the two-part controlled deployment of FIGS. 7, 8, 9,10, 11, 12, 13, 14, 15A, 15B, 15C and 15D for connecting the outersheath handle 710 to the inner screw handle 720 is illustrated in FIGS.16 to 23. These figures illustrate a mechanical handle 1600 that aids inthe controlled, accurate deployment of a stent graft. This configurationadds mechanical advantage to the retraction of the introducer sheath,which allows for a “smooth” retraction of the outer sheath by notpermitting the build up of potential energy, stored in the compressedstent graft, to cause an unexpected jumping or jerking motion duringouter sheath retraction.

A distal engagement portion 1612 of the outer sheath handle 1610 has aninternally threaded bore for receiving therein a threaded portion 1622of the inner screw handle 1620. In an exemplary embodiment, the distalengagement portion 1612 is made of DELRIN®. Engagement of the outersheath handle 1610 to the inner screw handle 720 (FIG. 7) is made byturning the outer sheath handle 1610 with respect to the inner screwhandle 1620. This causes the outer sheath handle 1610 to retract over orextend from the distal end of the inner screw handle 1620 in acontrolled fashion. Turning can be assisted with a proximal turn knob1624 rotationally fixed to the inner screw handle 1620.

The threaded portion 1622 extends for a longitudinal length that isgreater than the amount that is necessary to overcome greatest forcerequired for stent graft deployment. Once that greatest point of forceis overcome, the chance of handle jerk or slippage decreases and,therefore, the two handle portions 1610, 1620 can be movedlongitudinally freely with respect to one another. To achieve thetransition from longitudinal controlled and slow movement tolongitudinal free movement (and speedy if desired), at the proximal endof the threads of the screw handle 1620, a channel 1626 (or morechannels, e.g., two opposing channels) can be cut into the inner screwhandle 1620. A non-illustrated set screw is located at the distalengagement portion 1612 to protrude into the interior and engage thethreaded portion 1622. When the two handle portions 1610, 1620 arerotated sufficiently far to move the interiorly projecting set screwproximal of the threaded portion 1622, the set screw will ride directlyinto the channel 1626 (or the set screws directly into the channels1626). A set screw is desirable in this configuration because it can beused to increase and decrease tension for rotating the two handleportions 1610, 1620 with respect to one another. Changing the forceimparted against the threaded portion 1622 can be accomplished bydecreasing/increasing the depth of the set screw into the distalengagement portion 1612.

Functioning of the handle 1600 is illustrated, for example, in thediagrams of FIGS. 20 to 23. Before the inner screw handle 1620 is turnedto retract the outer sheath handle 1610, the outer sheath lumen 2010completely covers the stent graft 2020, which is loaded therein justbehind (proximal of) the nose cone 2030. The turn knob 1624 is rotatedto move the outer sheath handle 1610 proximally and begin to deploy thestent graft 2020 from the outer sheath lumen 2010. The user holds theinner screw handle 1620 longitudinally stationary while turning so thatthe outer sheath lumen 2010 moves proximally. An embodiment of the stepis shown in FIG. 21. Once the channels 1626 are completely disengagedfrom distal engagement portion 1612 of the outer sheath handle 1610, theouter sheath handle 1610 will rotationally lock into the channel(s) 1626while still being longitudinally free to move with respect to the innerscrew handle 1620. At this point, the bare stent 2110 and the firstsealing stent 2120 are exposed. After channel lock occurs, the proximalend of the stent graft 2020 is exposed from the outer sheath lumen 2010as shown in FIG. 21. With the set screw(s) locked into the channel(s)1624, the outer sheath handle 1610 can no longer rotate with respect tothe inner screw handle 1620 and, now, can be moved proximally as desiredby the user. Accordingly, the outer sheath lumen 2010 can be retractedso that the entire body of the stent graft 2020 is exposed as shown inFIG. 22. At this point, the outer sheath handle 1610 is positioned overthe inner screw handle 1620 and up to the turn knob 1624 and the stentgraft 2020 is only held to the delivery system 1600 by the apex claspdevice 2210. With release of the apex clasp device 2210, the stent graft2020 is freed from the delivery system 1600 and, thereafter, thedelivery system 1600 can be removed from the patient without impactingthe implantation of the stent graft 2020.

The delivery system 1600 of FIGS. 16 to 23 can be loaded with a 28mm×150 mm graft into a 19.5 French OD braided introducer sheath, forexample. In this configuration, the delivery system 1600 can deploy thebifurcated stent graft 2020 utilizing the mechanical advantage appliedby the screw mechanism to release the first section of the graft (barestent 2110 and sealing stent 2120). The remainder of the stent graft2020 can, then, be deployed by the pin-and-pull assembly of the deviceafter the threads 1626 are disengaged. This configuration eliminates anyrequirement to have the physician actively disengage the threads.

A further alternative to the two- or multi-part controlled deployment ofFIGS. 7 through 23 is illustrated in FIGS. 24 through 32. In general,these figures describe a “jogged slot” handle that aids in thecontrolled, accurate deployment of a stent graft. As set forth above,handles to be used on the delivery system of an AAA device need to gainbetter control over placement accuracy and/or to better fixate the AAAgraft during graft placement. The present invention provides a “joggedslot” (which can be configured in a similar manner as an automatictransmission shifter slot (i.e., stair steps)) to improve placementaccuracy. The “jogged slot” in this example utilizes stent graftdelivery system features described in the family of applicationsbeginning with U.S. Provisional Patent Application Ser. No. 60/499,652,filed Sep. 3, 2003, and U.S. patent application Ser. No. 10/784,462,filed Feb. 23, 2004, incorporated herein and including a slottedaluminum handle body, a distal handle grip, a proximal handle grip andthe proximal clasp assembly. The invention, however, is not limited tothis particular embodiment. If desired, the actuation knob can bereplaced with an end cap that serves to fixate the internal hypotube.

As shown in FIGS. 24 and 25, the internal mechanism of the handle 2400includes an internal tube 2500 with a jogged slot 2510 in which theslider assembly 2600 can slide from the distal portion of the handle2500 (shown in FIG. 24) to the proximal portion of the handle duringstent graft deployment. During deployment of the stent graft, the handle2400 with the jogged slot 2510 only permits the handle parts to move toa particular extent that is less than the total movement required forcomplete deployment of the stent graft. The jog or “Z” 2512 in the slot2510 has a circumferential or transverse portion 2514 preventing theproximal handle grip 2410 from moving all the way back to the end cap2420 without first having to be rotated circumferentially/transverselyaround the jog 2512. FIGS. 26 and 27 show that the slider assembly 2600can be, in an exemplary embodiment, a cylindrical hub with a barbedfitting at its distal end to receive the outer stent sheath 2610. At theproximal end of the slider assembly 2600 is an o-ring through which thesupport member hypotube passes. The slider assembly 2600 serves as bothan attachment point for the outer stent sheath 2610 to the handle and asa hemostasis port for flushing of the sheath lumen. Exiting from theside of the slider assembly 2600 is a “boss” 2700 that extends outward,through the slot 2442 in the handle body 2440, and attaches to theproximal handle grip 2410. The flush port runs through this boss 2700and attaches to the flush port tubing and valve 2710.

FIGS. 28 to 30 illustrate the attachment of the slider assembly 2600 tothe proximal handle grip 2410, which attachment allows actuation of thedelivery system 2400 and deployment of the stent graft from the outerstent sheath 2610. The outer stent sheath 2610, which is attached to theslider assembly 2600, is retracted in a proximal sliding motion(indicated by arrows A in FIG. 28) over the stent graft. Morespecifically, in this exemplary embodiment, the distal handle 2430 isheld stationary while the proximal handle grip 2410 is moved back(proximally) to deploy the stent graft. The internal support member thatis located coaxially within the outer stent sheath 2610 (see FIGS. 29and 30) serves as a platform or anchor to prevent the stent graft fromretracting along with the outer stent sheath 2610.

Significantly, the internal tube 2500 of the handle 2400 providesadvantages to permit controlled deployment (unsheathing) of the stentgraft. The internal tube 2500 in this exemplary embodiment is made frompolycarbonate material and is sized so that it can move freely withinthe slotted aluminum handle body 2440. The slider assembly 2600 is sizedso that it can move freely within the internal tube 2500. The internaltube 2500 has a straight tube running the full length of the handle2400. Machined through the wall of the internal tube 2500 is the slot2510 which is “jogged” in the manner of an automobile transmissionshifter. As such, the jogged slot 2510 provides a so-called stop 2514(or stops) that control deployment of the stent graft at differentpoints during the stent graft deployment sequence. The jog(s) 2512 thatis/are cut into the internal tube 2500 only allows the slider assembly2600 to move within that particular jog segment of the internal tube2500. Further retraction of the outer stent sheath 2610 requires theuser to actively turn the knob 2420 to a next setting, thus allowingfurther proximal movement of the slider assembly 2600. The boss 2700 ofthe slider assembly extends through the jogged slot 2510 of the internaltube 2500 and through the slot 2442 of the handle body 2440. The boss2700 is, then, connected to the proximal handle 2410. The internal tube2500 is attached at the distal end of the handle 2400 to the distalhandle 2430. Rotation of the distal handle 2430 allows rotation of theinternal tube 2500 within the handle body 2440.

FIGS. 31 and 32 show one exemplary embodiment for indicating a positionof the internal tube 2500 in the various stop positions. The indicatorcan be realized through either a viewing window 3200 withnumbers/letters or by color coded dots. From the package in which thesystem is delivered, the handle 2400 can be in a locked position(indicated, for example, with an “L”) of the jogged slot 2510. In thisorientation, the clinician could remove the handle 2400 from the packageand perform flushing procedures without a concern of prematurelydeploying the stent graft during handling. The clinician keeps thehandle 2400 in the locked position/state during insertion of the deviceinto the patient's artery and while tracking to the site of stent graftdeployment. The stop mechanism prevents any possibility of inadvertentproximal movement of the outer sheath 2610, which could partially deploythe stent graft.

Once the clinician identifies the deployment site and is ready to deploythe stent graft, he/she turns the distal handle 2430 until, for example,stop position 1 is obtained. With the device in stop position 1, theslot 2510 of the internal tube 2500 and the slot 2442 of the handle body2440 will be aligned, thus allowing the proximal handle 2410 to be slidproximally to allow partial stent graft deployment. Positioning of thenext exemplary jog or stop on the internal tube 2500 is set so that thesupra-renal struts and at least two stent graft springs (i.e., stents)are deployed from the outer sheath 2610. With the stent graft partiallydeployed, but with the suprarenal struts (i.e., of the bare stent) stillcaptured in the distal clasp mechanism, the stent graft can still bemaneuvered proximally or distally within the aorta to establish sealingsite positioning.

At this point, the clinician can fix the handle 2400 relative to thepatient to maintain the stent graft position relative to the aorta.Then, the clinician can move the distal handle 2430 to stop position 2and continue to move the proximal handle 2410 in a proximal directionuntil, for example, the contralateral leg of a bifurcated stent graft isreleased from the outer sheath 2610. The stop on the handle 2400 at theend of stop position 2 can, in an exemplary embodiment, prevent theipsilateral leg from deploying from the outer sheath 2610. Then, theclinician can rotate the handle 2400 to orient the stent graft'scontralateral leg to align with the patient's arterial anatomy. Once thestent graft is oriented properly, the clinician can actuate the distalclasp assembly and release the suprarenal struts. The capturedipsilateral leg, along with the anchored supra-renal strut and proximalseal serve as fixation during crossing of the guidewire into thecontralateral leg and subsequent placement of the contralateral leggraft placement. Once contralateral leg graft placement is achieved, thehandle 2400 is moved to stop position 3 and the proximal handle 2410 ispushed proximally to fully release the stent graft. The particularplacement/configuration of the stop positions is determined based uponvarious factors, including the size of the prosthesis and the featuresof the vessel in which the prosthesis is to be placed.

Yet another alternative to the multi-step controlled deployment of FIGS.7 to 32 is illustrated in FIGS. 33 to 51. These figures describe, ingeneral, an internal lead screw handle that aids in the controlled,accurate deployment of a stent graft. As indicated above, it isdesirable to gain better control over placement accuracy of an AAA graftduring stent graft placement with an AAA delivery system. The internallead screw embodiment described herein increases placement accuracy byallowing the operator to have more control over the initial deploymentof the stent graft.

An exemplary embodiment of a delivery system 3300 with an internal leadscrew that deploys a stent graft from a sheath is shown beginning withFIG. 33 and ending with FIG. 51. The delivery system 3300 has aninternal lead screw 3310 (see FIGS. 34, 35, 37), a lead screw nut 3320(see FIGS. 35 and 37), a lead screw rail 3330 (see FIGS. 36 and 37), adistal grip handle 3340, a flush port and a proximal end cap 3350. Thisconfiguration utilizes a support member 3360 with a hypotube at itsproximal end and a distal clasp assembly similar to the stent graftdelivery system described in the patent family previously incorporatedherein by reference. The lead screw nut 3320 can be actuated indifferent ways to deploy the stent graft from the outer sheath 3370. Oneexemplary actuation rotates the lead screw nut slowly to pull back onthe outer sheath 3370 using the threads of the internal lead screw 3310.Another exemplary actuation simply pulls back on the lead screw nut 3320to deploy the stent graft. By housing the internal lead screw 3310(which is formed, in this example, from cutting material on outerportions of a round threaded screw to a rectangular cross-section withthreads on only one side, i.e., a partial lead screw) within the leadscrew rail 3330, the system can bypass the need to always use the firstexemplary actuation process.

The support member 3360 is coaxially contained within the deliverysystem 3300. The support member 3360 is attached at its proximal end tothe proximal end cap 3350 of the handle 3300. The support member 3360travels coaxially through the internal lead screw 3310, the flush port,and the outer sheath 3370. At the distal end of the support member 3360is a capture pod that holds the proximal (caudal) end of the stentgraft. A guidewire lumen and the distal clasp assembly tubing (FIG. 39)travel coaxially within the support member 3360 along the full length ofthe delivery system 3300. Contained within the distal end of the outersheath 3370 can be the crimped stent graft and the distal claspassembly. The distal clasp assembly terminates at the distal end with aflexible tip 4100, shown in FIG. 41.

The lead screw 3310 (FIG. 33) used in this exemplary embodiment can bemade from a 1 inch diameter lead screw with a 0.400 inch linear lead perrotation of the lead screw nut. The internal lead screw 3310 isapproximately 14 cm in length and is machined so that most of thethreads are cut away from the circumference. Machining of the internallead screw 3310 is performed to allow the internal lead screw 3310 tofit in the lead screw rail 3330 and to allow the lead screw rail 3330 tofit between the internal lead screw 3310 and the lead screw nut 3320.The lead screw rail 3330 acts to center the lead screw nut 3320 on thepartial internal lead screw 3310. The diameter of the lead screw rail3330 is approximately equivalent to the minor diameter of the lead screwnut 3320. By locating the lead screw rail 3330 in this configuration,the internal lead screw 3310 can slide within the groove 3530 of thelead screw rail 3330 (FIG. 35).

Attached to the distal end of the internal lead screw 3310 is a flushport (FIG. 38). An O-ring is contained in the proximal end of the flushport, which seals around the support member hypotube. At the distal endof the flush port is a nipple that attaches to the outer sheath 3370.

During assembly of the device 3300 (shown, in part, in FIGS. 39 to 41),the stent graft is first loaded into the outer sheath 3370 along withthe distal clasp assembly and the guidewire lumen. Then, the distal tip4100 is threaded onto the distal clasp assembly. As shown in FIGS. 42and 43, the pre-assembled support member 3360 is then loaded into theouter sheath 3370. Then, the support member 3360 is guided through theflush port and the internal lead screw 3310. The outer sheath 3370 is,then, attached to the flush port and is clamped (see FIG. 38). As shownin FIG. 44, the handle body is assembled by first attaching the distalhandle grip 3340 to the lead screw rail 3330. Then, as shown in FIGS. 45to 46, the sub-assembly of the outer sheath 3370/flush port/internallead screw 3310 is threaded through the opening in the front of thedistal handle grip 3340 and the internal lead screw 3310 is set in thegroove 3430 of the lead screw rail 3330. FIGS. 47 to 48 show that thelead screw nut 3320 is passed over the lead screw rail 3330 and matedwith the internal lead screw 3310. The outer sheath 3370 is movedforward and the lead screw nut 3320 is threaded forward until itcontacts the distal handle grip 3340. As illustrated in FIGS. 49 to 51,the proximal end cap 3350 is, then, placed over the support member 3360and attached to the lead screw rail 3330. The support member 3360 issecured to the proximal end cap 3350 and the distal clasp mechanismhardware is installed.

In use, the clinician first flushes the system 3300 by forcing salinethrough the flush port. The saline fills the annular space between theouter sheath 3370 and the support member 3360, permeates through thecrimped stent graft, and exits between the outer sheath 3370 and theflexible tip 4100. The o-ring in the flush port seals the hypotube ofthe support member 3360 and prevents leakage through the delivery system3300. Then, the clinician feeds the delivery system 3300 over anindwelling guidewire and tracks the device to the stent graft deploymentsite.

At this point, the clinician has the option to either slowly release thestent graft by rotating the lead screw nut 3320 or rapidly release thestent graft by pulling back on lead screw nut 3320 and, thereby, slidingthe lead screw 3310 down the rail 3330. At some point in the deploymentof the stent graft, the release can be stopped to actuate the distalclasp assembly and release the leading struts (bare stent) of the stentgraft. Because the stent graft is usually severely constrained withinthe outer sheath 3370, deployment forces with AAA devices can be quitehigh.

The internal lead screw of the invention has the advantage ofincorporating a screw system to convert the linear force to a torqueforce. The torque force that the clinician must exert on the lead screwnut to deploy the stent graft is ergonomically less difficult than thelinear pull force. In addition to the mechanical advantage obtained withthe lead screw nut, the screw type mechanism allows for greater controlin the release of the stent graft. In a linear pin-and-pull system, thelargest force to deploy the stent graft is at the initial release offriction between the stent graft and the sheath. As soon as that initialfriction is overcome, the deployment force quickly declines. From anergonomic point of view, it is very difficult for a clinician tomaintain control and speed of the deployment at the moment when thefrictional forces are overcome. It is very common for the stent graft tobe un-sheathed more than was desired due to this loss of control. Ascrew type mechanism according to the present exemplary embodimentallows the clinician to have more control over this initial release ofthe stent graft, which is a critical factor for stent placementaccuracy.

FIGS. 52 to 54 illustrate an improvement to the lead screw embodiment ofthe previous figures. In the above embodiment, the user was required togrip and turn the handle knob with one hand while holding the sheathhandle grip with the other hand. See FIG. 52. Actuation of this handlerequired the user to concentrate on two motions at once for deploymentof the stent graft. Also, there was a possibility of turning thehypotube/inner member out of alignment with the sheath hub, whichmisalignment could decrease stent graft placement accuracy. Therefore, asecond handle 5300 was added behind (proximal) the turn knob 5310 (FIGS.53 and 54). The handle 5300 is attached to the bearing engagement thatis affixed to the inner member 5360 (hypotube). The user grips thesecond handle 5300 and turns the lead screw knob with the thumb andpointer finger. Now, the user's hand is pinned in one location as theknob is turned and the sheath handle is retracted back over the leadscrew.

FIGS. 55A through 57 illustrate another exemplary embodiment of thedelivery systems of the present invention. This example of the deliverysystem 5500 includes features of the pin-and-pull telescopic systems100, 700, 1600, 2400 and the system 3300. The delivery system 5500 hasan internal lead screw 5510, a lead screw nut 5520, a hollow distal griphandle (also referred to herein as “distal grip”) 5530, and a hollowinterior body 5540 (also referred to herein as “handle body”). Theinternal lead screw (also referred to herein as “internal lead screwassembly”) 5510 rides within a track 5542 of the hollow interior body5540. The lead screw nut 5520 has a non-illustrated interior threadhaving a pitch corresponding to upper thread portions (also referred toherein as “threaded portion”) 5512 to cause longitudinal movement of theinternal lead screw 5510 when rotated about the hollow interior body5540. Thus, the lead screw nut 5520 is rotatably freely mounted aboutthe hollow interior body 5540. The lead screw nut 5520 is alsolongitudinally freely mounted about the hollow interior body (alsoreferred to herein as “handle body”) 5540. In this configuration, theclinician has the ability to rotate the lead screw nut 5520 to anydesired retraction of the internal lead screw 5510. At any time before,during, or after such rotation, the clinician can move the lead screwnut 5520 longitudinally proximal, taking the internal lead screw 5510along with it at the same speed of proximal movement of the lead screwnut 5520. The internal lead screw 5510 is longitudinally fixed to theouter sheath 5550, which is longitudinally free from the hollow distalgrip handle 5530 and the hollow interior body 5540. In this manner,rotation of the lead screw nut 5520 moves the outer sheath 5550relatively slowly (dependent upon the pitch of the threads of threadedportion 5512), and longitudinal movement of the lead screw nut 5520moves the outer sheath 5550 relatively fast.

The difference between FIGS. 55A and 56 illustrates the relativepositions of the internal lead screw 5510, the hollow distal grip handle5530, the hollow interior body 5540, and the outer sheath 5550 after thelead screw nut 5520 has been moved proximally to (about) itsproximal-most position. In FIG. 55A, the outer sheath 5550 surrounds thepush rod 5560 and completely covers the cavity within the outer sheath5550 in which the non-illustrated stent graft is stored (compressed)prior to implantation. The outer sheath 5550 extends all the way totouch the nose cone 5570 and form a seal therewith to reliably securethe stent graft therein. In FIG. 56, in comparison, the outer sheath5550 can be seen completely retracted from the nose cone 5560 to clearthe indented boss 7000 at the distal end of the push rod 5560. The apexcapture assembly 5568 for removably securing the bare stent (e.g., 2310)of the stent graft is shown just proximal of the nose cone 5570 and inthe closed (secured) position of the apex capture assembly 5568.Actuation of the apex release device 5580 moves the inner lumen 5590connected to the proximal apex capture portion 5572 (with itsbare-stent-capturing tines) proximally to create a space through whichthe individual proximal apices of the bare stent can escape.

It is noted that the entire device disposed in the interior of thehollow distal grip handle 5530 shown in FIG. 55A is not shown in FIG.56. This device, slider 5700, is shown, in enlarged detail, in FIG. 57A.From distal to proximal, the outer sheath 5550 is secured by a sheathclip 5702 to a distal nipple of a slider cap 5710. The slider cap 5710has a check or flush valve (also referred to herein as “flush valveorifice”) 5712 fluidically connecting the inner chamber of the slidercap 5710 to the environment outside the flush valve orifice 5712. Anintermediate slider assembly (also referred to herein as “slider body”)5720 is secured to the slide cap 5710 with an o-ring 5730 therebetweento keep the respective interior chamber fluidically connected to oneanother and fluidically sealed from the environment outside the twoparts slider cap 5710, and slider body assembly 5720.

A release 5514 (e.g., a thumbscrew) removably secures the slider 5700inside the hollow distal grip handle 5530 and hollow interior body 5540when the release is placed inside a blind hole 5722 of the slider bodyassembly 5720. With the release 5514 removed/actuated, all of the partsillustrated in FIG. 56 can be removed from the slider 5700 except forthe outer sheath (also referred to herein “sheath”) 5550—this includesthe entire distal section with the support member 5740, the apex releasedevice 5580 and the nose cone 5570.

As the above delivery systems, a support member 5740 runs entirelythrough the slider body assembly 5720 and all the way back to the apexrelease device 5580. This support member 5740 needs to be sealed to theslider 5700 so that blood flow outside the member is not allowed. Toeffect this seal, a wiper gasket seal (also referred to herein as “wipervalve”) 5750 is provided inside the cavity of the slider body assembly5720. The seal is enhanced with the use of an x-valve 5760.

The apex capture device assembly of the invention can be employed inconjunction with the leg clasp of the invention, as shown in FIG. 128.The lumen 8613 and elongate member 8614 extends from apex capturedelivery device assembly 12802 through leg clasp 12810. Bifurcated stentgraft 12803 extends from apex capture device 12804 to leg clasp 12810,and is secured at each of apex capture device 12804 and at leg clasp12810 as described above, and for release according to the method of theinvention, as also described above.

In an embodiment, the invention is a stent graft delivery device,comprising, an apex capture device assembly, including (1) a proximalapex capture portion, including a nose, wherein the nose defines atleast one radial restraint that is substantially parallel to a majoraxis of the proximal capture portion; and a plurality of tines extendingdistally from the nose, the tines radially distributed about the majoraxis radial to a most proximal radial restraint and substantiallyparallel to the major axis, (2) a distal apex capture portion definingslots distributed radially about the major axis, the slots mateable withthe times by relative movement of the proximal and distal apex captureportions along the major axis, (3) a plurality of bosses extendingradially from the major axis between the nose and the distal apexcapture portion and aligned with the slots along the major axis innon-interfering relation with movement of the tines into mating relationwith the slots, (4) an elongate member 8614, otherwise known as an innercontrol tube, to which the distal apex capture portion is fixed, theelongate member extending through the proximal apex capture portion andthe plurality of bosses, (5) a lumen 8613, otherwise referred to as anouter control tube, to which the proximal apex capture portion is fixed,through which the elongate member extends, whereby movement of the lumencauses movement of the proximal apex portion along the major axisbetween a first position, in which the tines are mated with the slotsand overlie the bosses, and a second position, in which the tines arenot mated with the slots and do not overlie the bosses, (6) a bare stentthat includes struts linked by apices, the struts extending between thetines, a portion of the apices extending between the bosses and thedistal apex capture portion when the tines are mated to the slots and(7) at least one suprarenal barb extending from the stent into theradial restraint; and a leg clasp through which the elongate member andlumen extend, the leg clasp including, (1) a barrel, (2) a spoolextending from the barrel along a major axis of the barrel, and (3) arim at an end of the spool, the rim having a diameter greater than thatof the spool but less than that of the barrel.

In another embodiment, the invention is an x-valve assembly, comprisingan x-valve; and a gasket supporting the x-valve. The gasket includes aperipherial support and at least one arm extending inwardly from theperipherial support. In an embodiment, the gasket includes at least twopairs of arms, along intersecting major axes. In an embodiment, eachpair of arms is aligned. At least two of the axes of the x-valveassembly can be normal to each other. The pairs of arms in the x-valveassembly can lie in a plane. The gasket of the x-valve assembly caninclude a superelastic metal, which can include nitinol.

X-valve assembly 5760 can be seen in greater detail in FIG. 57B. Asshown therein, x-valve assembly 5760 includes gasket support 5762 andvalve 5764. Gasket support 5762 is shown separately in FIG. 57C. Gasketsupport 5762 typically includes superelastic metal, such as nickeltitanium (i.e., nitinol). X-valve 5764 is shown separately in FIG. 57D.Valve 5764 typically is formed of silicone. A partially exploded view ofx-valve assembly 5760 slider assembly 5720 is shown in FIG. 57E. Anotherperspective of a partially exploded view of x-valve assembly 5760 inslider assembly 5720 is shown in FIG. 57F. Slider assembly 5720components shown in FIGS. 57E and 57F include slider body 5766 andgasket spacer 5768. The slider body and gasket spacer typically formedof polyetheretherketone (PEEK). With this configuration, when thesupport member 5740 is in the slider 5700 as shown in FIG. 57A, bloodflow outside the slider 5700 is substantially prevented when theproximal end of the support member 5740 is sealed). The flush valveorifice 5712, therefore, is the only way for blood flow to occur, butonly if the blood surrounds the support member 5740.

As set forth above, the support member 5740 can be removed from withinthe slider 5700. While the wiper valve seal 5750 and the x-valve 5760form some or even a substantial measure of sealing capability, theblood-tight seal needs to be ensured. Accordingly, a sealing assembly isprovided at the proximal end of the slider 5700, which sealing assemblyis comprised, in one exemplary embodiment, of a sheath valve 5770, asheath valve washer 5780, and a sheath valve knob 5790. As described inthe following text, the sheath valve washer 5780 is not necessary but isincluded in this embodiment. The sheath valve 5770 here is formed as acylindrical piece of silicone but can take any shape or material so longas, when compressed inside the slide assembly 5720, it creates ablood-tight seal inside the blind hole 5722 of the slide assembly 5720.With the configuration shown in FIG. 57A, the sheath valve knob 5790 isconnected into the proximal end of the slide assembly (also referred toherein as “slider body”) 5720 with a thread so that, when rotated withrespect to the slide assembly 5720, the knob 5790 enters into or removestherefrom. Thus, after removal of the interior assemblage, (as the nosecone is being withdrawn from the slide assembly 5720, with appropriaterotation, the knob 5790 pushes the sheath valve washer 5780 inwardsagainst the sheath valve 5770 to compress the sheath valve 5770 onitself and seal up the hole left after the support member 5740 and allof the interior assemblage is removed. In a particular embodiment of thesheath valve 5770, an annular groove 5772 on the outside diameter of anintermediate portion of the sheath valve improves a self-sealingcollapse of the sheath valve 5770. Easier collapse is desired because ofthe strain that the user experiences when having to rotate the knob 5790with greater resistance. The groove 5772 significantly reduces the forcerequired and the number of knob turns required.

FIGS. 58 to 60 illustrate exemplary embodiments of the nose cone of thedelivery systems of the present invention.

A passive hemostasis valve for the delivery systems 100, 700, 1600,2400, 3300, 5500 can replace the sheath valve 5770 in the system 5700 ofFIG. 57. Hemostasis can be maintained by two components. First, a sealon the guidewire can be made by a “duckbill” type valve. The duckbillcan have mechanical assist, for example, such as by two spring-loadedrollers, to ensure the seal. The seal on the sheath of the second deviceis maintained by a rubber disc having a hole slightly smaller than thesheath it will receive. This component also maintains hemostasis for themain system.

FIGS. 65 to 69 illustrate an exemplary embodiment of a leg-extensiondelivery system according to the invention (as compared to the main orbifurcated delivery system as shown, for example, in FIGS. 55A to 57.The measurements shown in these figures are not to be taken as the onlyembodiment and, instead, should be taken as only exemplary for theinvention.

The above-described delivery systems 100, 700, 1600, 2400, 3300, 5500each require the stent graft to be loaded within the outer sheath lumenand each have an interior device that both prevents the stent graft frombeing inserted too far into the sheath lumen and keeps the stent graftlongitudinally fixed when the outer sheath is being retracted over thestent graft. When implanting a bifurcated stent graft, it is desirableto ensure that the last two springs (e.g., stents) of the ipsilateralleg are not prematurely released from the outer sheath duringdeployment. The invention, shown in FIGS. 70A, 70B and 70C, allows thecapture of the stent graft's ipsilateral leg while the contralateral legis cannulated. Such a configuration ensures stability of the stent graftduring the cannulation of the contralateral leg.

An additional embodiment of the invention shown in FIGS. 70A, 70B and70C, as an example, is a leg clasp 7001, comprising a barrel 7002; aspool 7004 extending from the barrel 7002 along a major axis of thebarrel 7002; and a rim 7006 at an end of the spool 7004, the rim 7006having a diameter greater than that of the spool 7004 but less than thatof the barrel 7002, as shown in FIGS. 70A, 70B and 70C.

The leg clasp 7001 of the invention can formed, at least in part, of atleast one component selected from the group consisting of stainlesssteel, polyester, polyetheretherketone (PEEK) and acrylonitrilebutadiene styrene (ABS). The rim 7006 of the leg clasp 7001 of theinvention can include radially extending spokes 12502, as shown in FIGS.125 and 126.

In still another embodiment, the invention is a stent graft deliverysystem, comprising a leg clasp 7001 that includes a barrel 7002, a spool7004 extending from the barrel 7002 along a major axis of the barrel7002 and a rim 7006 at an end of the spool 7004, the rim 7006 having adiameter greater than that of the spool 7004 but less than that of thebarrel 7002; a support tube 7010 fixed to the barrel 7002 and extendingfrom the barrel 7002 in a direction opposite that of the spool 7004; anda sheath 7030 (FIGS. 70A and 70C) having an internal diameter relativeto that of the barrel to permit movement between a first position thatcovers the spool 7004 and rim 7006 and a second position that exposesthe spool 7004 and rim 7006. It is to be understood that support tube7010 is also represented as support tube 5744 in FIG. 57B, and that, inan alternative embodiment, some other component of support member 5740,shown in FIG. 57B, can be fixed to barrel 7002, such as hypo-tube 5742,also shown in FIG. 57A, and that support tube 7010 can be fixed directlyto hollow interior body 5540, shown in FIG. 56.

The stent graft delivery system of the invention can further include astent graft 7020, wherein a stent 7024 of the stent graft extends aboutthe spool 7004 in interfering relation with the rim 7006 when the outersheath 7030 is in the first position, and a luminal graft 7032 to whichthe stent is fixed extends between the rim and the sheath, wherebymovement of the sheath from the first to the second position releasesthe stent graft from the leg clasp.

In particular, an indented boss 7000 is placed at the distal end of thepush rod (also referred to herein as “support member”) 7010, whichprevents the stent graft 7020 from being inserted too far into the outersheath 7030 and keeps the stent graft 7020 longitudinally fixed when theouter sheath 7030 is being retracted over the stent graft 020. Theindented boss 7000 has a proximal flange (also referred to herein as a“barrel”) 7002, an intermediate span (also referred to herein as a“spool”) 7004, and a distal flange (also referred herein as a “rim”)7006. The outer diameters of the proximal and distal flanges 7002, 7006are larger than the outer diameter of the intermediate span 7004 tocreate an annular cavity 7008 therebetween. If the stent graft leg 7022is placed over the distal flange 7006 sufficiently far to have thedistal-most stent 7024 within the annular cavity 7008, the indented boss7000 creates an interference fit between the leg 7022 and the outersheath 7030. Once the outer sheath 7030 is completely retracted, theinterference fit disappears. It can be said that the fixation of thelast stent 7024 is passive due to the fact that, after the outer sheath7030 is retracted, the fixation is lost. This configuration can be usedto better control and grasp the stent graft 7020 by preventinglongitudinal movement thereof when the outer sheath 7030 is retracted(to the left of FIG. 70A).

The following sections discuss improvements to stent grafts, inparticular, bifurcated AAA stent grafts intended to span the renalarteries. As shown in FIGS. 72A, 72B, 72C through FIG. 83, a stent graftsystem, such as bifurcated stent graft system 7200, comprising a luminalgraft component 7201; a bare stent component 7210 including a pluralityof struts 7211 joined by proximal 7212 and distal 7213 apices connectingthe struts 7211, the bare stent component 7210 fixed to a proximal end7214 of the luminal graft component 7201 and extending proximally fromthe proximal end 7214; an infrarenal stent component 7215 proximate tothe bare stent component 7210, wherein the infrarenal stent component7215 is distal to the bare stent component 7210 and spans acircumferential line defined by apices 7213 of the bare stent component7210 fixed to the luminal graft component 7201; at least one suprarenalbarb 7220 extending distally from at least one suprarenal portion 7217of the bare stent component 7210; and at least one infrarenal barb 7230extending distally from at least one infrarenal portion 7218 of the barestent 7210.

“Suprarenal,” as used herein in reference to a barb, means a barb thatattaches to the aorta cranial to the ostium of the most superior renalartery.

“Infrarenal,” as used herein in reference to a barb, means a barb thatattaches to the aorta caudal to the ostium of the most inferior renalartery.

In another embodiment, an infrarenal barb can be a first covered barb.Bare stent is also referred to as “uncovered” or “partially” coveredstent.

“Barb” is also referred to herein as “hook.”

As shown in FIG. 73, in the stent graft system of the invention, thesuprarenal portion of the bare stent 7210 can include a bridge 7219between struts 7211 to define an eyelet 7221 that joins two struts 7211,and wherein the suprarenal barb 7220 extends from the bridge 7219.

The infrarenal barb 7230 of the stent graft system of the invention canextend from a distal apex 7213 that joins two struts 7211.

Exemplary distances between the most proximal point of the suprarenaland infrarenal barbs of the stent graft system of the invention is in arange of between about 6 mm and about 40 mm (e.g., 6 mm, 10 mm, 15 mm,20 mm, 25 mm, 30 mm, 35 mm, 40 mm).

At least one of the stents of the stent graft system of the inventioncan include a superelastic metal, such as nickel titanium.

In an embodiment, the distal apices of a bare stent of the stent graftsystem of the invention are fixed within the luminal graft component andwherein the infrarenal barb extends from the bare stent through thelumen. At least one infrarenal stent of the invention can be fixedwithin the luminal graft component.

Another embodiment of the invention, shown in FIG. 105C is a stent graftsystem 10550, comprising a luminal graft component 10560; a bare stent10570 of angled struts 10580 joined by proximal 10590 and distal 10591apices, and extending from a proximal end 10592 of the luminal graftcomponent 10560; a proximal stent 10593 adjacent the bare stent 10570and within the luminal graft 10560, the proximal stent 10593 includingangled struts 10580 joined by proximal apices 10590 and optionallydistal apex 10591 nested with the bare stent 10570; and at least onebarb 10594 extending distally from a distal apex 10591 and through theluminal graft component 10560.

FIG. 71 diagrammatically illustrates an abdominal aorta 7100 with ananeurysm 7110 between the renal arteries 7120 and the iliac arteries7130—the abdominal aorta 7100 branches, at its downstream end, andbecomes the left and right common iliac arteries 7130, carrying blood tothe pelvis and legs. FIGS. 72A, 72B and 72C diagrammatically illustratesa stent graft system, such as a bifurcated stent graft system 7200having a graft portion that extends from just downstream of the renalarteries 7120 towards the iliac arteries 7130, splitting into twosmaller lumens, one of which extends into an iliac artery 7130 and theother ending before the other iliac artery 7130. The bare stent 7210 ofthis bifurcated stent graft 7200 is configured with both suprarenalbarbs 7220 and infrarenal 7230 barbs.

Another embodiment, shown in FIG. 72B the invention is a stent graftsystem 7200, comprising a luminal graft component 7201; a bare stent7210 extending from a proximal end 7214 of the luminal graft component7201, such as a bifurcated luminal graft component; at least oneproximal barb 7220 extending distally from a proximal end 7217 of thebare stent 7210; and at least one distal barb 7230 extending distallyfrom an infrarenal portion 7218 of the bare stent 7210, the distance, a,between the proximal 7220 and distal 7230 barbs along a major axis ofthe luminal graft component being in a range of between about 6 mm andabout 40 mm (e.g., 6 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40mm).

In the stent graft system of the invention, at least a portion of thebarbs extend from the bare stent at an angle in a range of between about20 degrees and about 60 degrees (e.g., 20 degrees, 25 degrees, 30degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60degrees).

A bare stent of the stent graft system of the invention can be formed,at least in part, of a superelastic metal.

As shown in FIGS. 78 and 79, the stent graft systems of the inventioncan further include at least one radiopaque marker 7800. At least oneradiopaque marker attached to the stent graft systems of the invention,either to the stent or the graft material, can aid in the place of thestent graft in a patient by employing stent graft delivery systems ofthe invention, for example, in methods of treating abdominal aorticaneurysms.

FIGS. 73 to 75 illustrate various features of a suprarenal bare stent7210 with hooks or barbs 7212 according to an exemplary embodiment ofthe invention an AAA stent-graft system. A 6-apex version is shown,although more or less apices could be used. This bare stent 7220, 7230has, as shown in FIG. 74, different length hooks 7410, 7420, 7430 that,for example, increase in length based upon the distance from the graftedge (of course, these lengths can decrease in this direction or be acombination of lengths). In an embodiment, the hooks 7410, 7420, 7430increase in length the further away from the graft edge (i.e., B-1 islonger than B-2 and is longer than B-3) because, in an angled neck,hooks further from the graft line are more likely to be further from theaortic wall. Further, shorter hooks nearer to the renal arteries issafer for patients.

FIG. 75 shows an orientation where hooks 7510, 7520, 7530 increase inlength further away from the graft edge and are disposed at staggeredpositions along various circumferential planes at distances from thegraft edge.

FIGS. 73 through 75 and 77 illustrate an eyelet 7700 at each apex at thegraft end (distal) of the bare stent. This feature assists in suturingthe stent to the graft material. Benefits of the eyelet include suturingin an area of the stent with no stresses or strain during normalpost-sewing process steps. Typically, stents are sewn around theintrados of the sinusoid of the stent. This area will be subjected toelastic deformation during post sewing process steps likecrimping/loading and final deployment. Such movements can only havedetrimental effects on the sutures. Additionally, during normalanatomical movements in the body, the intrados of the stent will havethe most movement. An eyelet, as shown in these figures, will not besubject to any movement or plastic deformation that would beyond thegeneral movement of the whole prosthesis. Suturing in the area of astent that will not be subject to any stresses or strain is advantageousfrom a manufacturing perspective. During the sewing process, the needlescan cause small gauges in the stent, which could become focal points forcrack initiation and subsequent fracture. These gauges would be of muchgreater concern in the intrados than in a static area such as the eyelet7700. Should the suprarenal stent of the invention be subjected to afracture after implant, the intrados area of the stent is likely to be aspot where the fracture would occur. If the suture is done in this spot,a fracture could result in the complete disassociation of the suprarenalstent from the graft. By sewing on this added eyelet feature, afractured stent would still have one of the two struts attached to thegraft after that fracture. Thus, once a fracture occurred, it would befar less likely for the second strut in the same area to also break awayfrom the shared intrados. Having the inferior eyelets shown as thesuture securement areas of the stent has significant advantages:

Stents of the invention can be of a size from about 20 mm to about 36mm, and include, for example, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm,33 mm, and 36 mm.

The stent can be cut from a 3 mm OD tube, for example. The width of thecan be equivalent (but not need be equivalent) to the circumference of a3 mm tube. The tubing wall can be, for example, 0.017″. FIGS. 81 to 85illustrate one exemplary embodiment of a laser-cut supra-renal stentwith side hooks according to the invention with exemplary measurementsfor the stent when being manufactured from such a tube. This exemplaryembodiment includes 6 superior and 6 inferior apices, although variantscould have more or less. Strut thickness can be targeted to mimic a wireof approximately 0.016″ to 0.018″ diameter. But can be of varyingdiameters, for example, the wall thickness can be 0.017″.

Barbs can be bent out of plane and sharpened as part of a finishingprocess. All of the barbs, or only a subset of the barbs, may beincluded in the stent of the invention.

The bare stents described above are to be used with the delivery systemsaccording to the invention, which systems include distal apex capturedevices, an example of which is shown in FIG. 69. With the addition ofthe barbs, however, the spaces that previously existed between each ofthe stent arms 8010 (i.e., the lengths between the apices) is now takenup by the barbs. This can be seen, in particular, in FIGS. 80 and 84.Accordingly, the apex capture device previously used is modified to takeaccount of the lost of “space” between the arms 8010.

In an embodiment, the invention is an apex capture device 8600,comprising a proximal apex capture portion 8600 a that includes a nose8601, wherein the nose defines at least one radial restraint, such as apilot holes, represented as 8011, in FIGS. 86C and 88, that issubstantially parallel to a major axis of the proximal capture portion8600 a and a plurality of tines 8602 extending distally from the nose8601, the tines 8602 are radially distributed about the major axisradial to a most proximal radial restraint and are substantiallyparallel to the major axis; a distal apex capture portion 8610 definingslots 8611 distributed radially about the major axis, the slots 8611mateable with the tines 8602 by relative movement of the proximal 8600 aand distal 8610 apex capture portions along the major axis; a pluralityof bosses 8612 extending radially from the major axis between the nose8601 and the distal apex capture portion 8610 and aligned with the slots8611 along the major axis in non-interfering relation with movement ofthe tines 8602 into mating relation with the slots 8611; an elongatemember 8614, shown in FIG. 86D, (also known as an inner control tube) towhich the distal apex capture portion 8610 is fixed, the elongate member8614 extending through the plurality of bosses 8612 and the proximalapex capture portion 8600 a; and a lumen 8613, also shown in FIG. 86D,(also referred to as an outer control tube) to which the proximal apexcapture portion 8600 a is fixed, through which the elongate memberextends, whereby movement of the lumen 8613 causes movement of theproximal apex capture portion 8600 a along the major axis between afirst position, in which the tines 8602 are mated with the slots 8611and overlie the bosses 8612, and a second position, in which the tines8602 are not mated with the slots and do not overlie the bosses 8612.

“Radial restraint,” as used herein, means restricted movement in adirection normal to the major axis of the delivery system or the apexcapture device, whereby, for example, a barb of a stent could bereleased between tines of the apex capture device.

“Non-interfering relation,” as used herein, means one object is moveablerelative to another object.

The nose 8601 of the apex capture device of the invention can definegrooves 8603 between the tines 8602, wherein the grooves 8603 arealigned with spaces between the bosses 8612.

In an embodiment, the plurality of bosses 8612 of the apex capturedevice of the invention are fixed relative to distal apex captureportion 8610.

The nose, elongate member and each of the tines 8602 of the apex capturedevice of the invention can define a space.

In another embodiment, the invention is a method of releasing a barestent of a stent graft, comprising the steps of moving a lumen, to whicha proximal apex capture portion of an apex capture device is fixed, theproximal apex capture portion defines a radial restraint, along a majoraxis between a first position, in which tines of the proximal apexcapture portion are mated with slots of a distal apex capture portionand overlie bosses extending radially from a major axis of the apexcapture device, and a second position, in which the tines are not matedwith the slots and do not overlie the bosses, thereby releasing apicesof a bare stent from a space defined by the tines, the bosses and thedistal apex capture portion.

In an embodiment, the apex capture device employed in the method ofreleasing a bare stent of a stent graft can further include an elongatemember to which the distal apex capture portion is fixed, the elongatemember extending through the proximal apex capture portion and theplurality of bosses.

In another embodiment, the apex capture device employed in the methodsof the invention can further include a lumen to which the proximal apexcapture portion is fixed, through which the elongate member extends, andby which the proximal apex capture portion is moved.

In yet another embodiment, the invention is an apex capture deviceassembly 7600, comprising a proximal apex capture portion 7610 thatincludes a nose 7615, wherein the nose defines at least one radialrestraint, such as a pilot hole, previously described, that issubstantially parallel to a major axis of the proximal capture portionand a plurality of tines, previously described extending distally fromthe nose 7610, as shown, for example, in FIG. 76A, the tines radiallydistributed about the major axis radial to a most proximal radialrestraint and substantially parallel to the major axis; a distal apexcapture portion 7620, as shown, for example, in FIG. 76A, defining slotsdistributed radially about the major axis, the slots mateable with thetimes by relative movement of the proximal and distal apex captureportions along the major axis; a plurality of bosses extending radiallyfrom the major axis between the nose and the distal apex capture portionand aligned with the slots along the major axis in non-interferingrelation with movement of the times into mating relation with the slots;a elongate member to which the distal apex capture portion is fixed, theelongate member extending through the proximal apex capture portion 7610and the plurality of bosses; a lumen to which the proximal apex captureportion 7610 is fixed, through which the elongate member extends,whereby movement of the lumen causes movement of the proximal apexportion along the major axis between a first position, in which thetines are mated with the slots and overlie the bosses, and a secondposition, in which the tines are not mated with the slots and do notoverlie the bosses; a bare stent 7630 that includes struts 7631 linkedby apices, the struts extending between the tines 8602 (FIG. 86B), aportion of the apices extending between the bosses and the distal apexcapture portion when the tines are mated to the slots; and at least onesuprarenal barb 7632 (FIG. 76B) extending from an eyelet of the stentinto the radial restraint (not shown).

The stent of the apex capture device assembly of the invention canfurther include at least one bridge between a pair of the struts todefine an eyelet through which a boss extends when a tine is mated to aslot, and wherein the barb extends from the bridge.

In an alternative embodiment, shown in FIG. 76B, the struts 7634 areangled. The struts are angled as a result of clasping the bare stent andrestraining the barbs thereby creating a deeper valley for at least oneinfrarenal barb.

Referring to both FIGS. 76A and 76B, the suprarenal barb of the apexcapture device assembly of the invention is angled (not shown) from amajor plane of the eyelet sufficient to distend the struts to which theeyelet is attached toward the major axis.

The apex capture device of the invention can further include aninfrarenal barb 7635 extending from a distal apex 7636 of the stent7630.

The apex capture device assembly of the invention can further include aluminal graft component 7637 fixed to a distal portion of the bare stent7630 and an infrarenal stent 7638 adjacent and distal to the bare stent7630, the infrarenal stent 7638 including struts 7639 linked by proximal7640 and distal 7641 apices, the distal apices 7641 being substantiallyaligned with distal apices 7636 of the bare stent 7630. In anembodiment, the infrarenal stent 7638 of the apex capture deviceassembly 7600 of the invention is fixed within the luminal graftcomponent 7637. Distention of the bare stent struts 7631, 7634consequent to retention of the barbs 7632 within the radial restraint,such as a pilot hole 8011 (FIG. 86C), can cause the infrarenal barb 7635of the bare stent 7630 to be recessed between struts 7639 of theinfrarenal stent 7638.

For example, as shown in FIGS. 86A, 86B, 86C, 86D and 86E through 88,the proximal apex capture portion 8600 having the tines 8602 is in thebare stent release position, in which it is separated from the distalapex capture portion 8610 (which is connected to the nose cone 6860(FIG. 88A)). The upstream apices of the stent 8620 (FIG. 87A), whilecaptured and before springing open upon final deployment, are wrappedaround holding bosses 8612 that circumferentially align with arespective one of the tines 8602 and, therefore, extend radially outwardto touch the respective tine 8602, or come close enough to prevent anystent apex release when closed over by the tines 8602. To complete thecapture cavity for the stent apices, the distal apex capture portion8610 has recesses 8816 that are shaped to fit snugly the distal-mostends of each one of the tines 8602. Accordingly, the recesses 8611 ofdistal apex capture portion 8610 are circumferentially offset from thebosses 8612, as represented in FIGS. 86A-86E. Elongate member 8613extends from proximal capture portion 8600.

Prior art Z-stents are made of a single length of wire joined at the twoends. Provided herein, and shown in an exemplary embodiment in FIGS. 89and 90, is a multiple-stent 8900 made with a plurality ofcircumferentially adjacent filaments. There are various features thatexist with the multiple-stent 8900 that do not arise in prior artstents.

The multiple-stent 8900 is a wire form stent made from wire that issubstantially smaller in diameter than used in prior art stents/stentgrafts. In spite of this substantial reduction in diameter, the multipleturns around the circumference create a total metal cross-section oneach strut of each stent similar to prior art stents. Having multipleturns in the multiple-stent 8900 creates multiple apices 8910 at eachbend of the composite stent 8900. These apices can be used to improveimplantation on an interior wall of a vessel to be treated.Additionally, each of these apices 8910 can be used to catch onto thegraft material of a second modular component, for example, on the graftmaterial of a second part of a bifurcated stent graft that is to bedeployed in the iliac artery opposite the long downstream leg of thebifurcated stent graft. One particular use is that these apices 8910 canbe used to catch onto opposing apices of a stent from the second modularcomponent. The multiple-stent 8900 can be used in any overlap region.Variations of the multiple-stent 8900 can include wire diameter, overallnumber of apices as well as the number of turns (filaments) used.

The multiple-stent 8900 can be made from a single wire circumferentiallyrepeated as shown in FIGS. 89 through 94. The embodiment of FIG. 89stacks the apices 8910 and the embodiment of FIG. 91 encircles theapices 9100. Alternatively, the multiple-stent can be a plurality ofindependent Z-stents intertwined with one another.

To use the multiple-stent to connect two modular components of astent-graft system, the graft and stent are assembled in a non-intuitivemanner to achieve a high modular tensile strength. The graft isassembled such that its longitudinal length is shortened by folding thelumen in on itself in a longitudinal direction. This is done so that thetotal effective lumen is substantially unchanged, with respect tointernal diameter. The ability to fold the lumen in on itself is done bysewing consecutive leg stents further from one another than wouldnormally be done. FIG. 95 shows a cutaway graft with the surfaces on thebottom representing the portion of the lumen that is folded into theupper lumen. Overall, the graft is still a single lumen. FIG. 96 is aclose-up of the in-folded area of the graft. Significantly, this fold9600 creates a pocket 9610 facing the proximal end of the graft, when inthe lumen of the graft. FIG. 97 is a photograph of an example of theconfiguration of FIGS. 95 and 96 applied to both iliac ends of abifurcated stent graft. This particular example shows the fold betweenthe last stent on the right and the stent immediately adjacent the laststent to the left in the figure. If desired, this configuration is seton both legs of the bifurcate as shown in FIG. 97.

These folds 9600 are placed in the areas of the stent graft that willreceive modular components. Accordingly, the folds 9600 are made nearthe distal ends of stent graft components. These folds 9600 can be doneat multiple points along the length, and can also be done at the veryend, or at both locations. To keep the folds 9600 in place, longitudinalstitches are sewn through all the layers of the graft. These stitchesare shown with reference “A” in FIG. 97. If the fold is at the end of asegment, like the stitch shown on the longer leg (top of FIG. 97), therewill be two layers of graft material. If, in comparison, the stitch A isbetween two stents (bottom of FIG. 97), then three layers of graftmaterial will be present. Folding of the graft components is done tocreate pockets on the lumen of the grafts. These pockets are used toreceive the second component of the modular securement mechanism, thestent.

The multiple-stent that is attached to a graft is found at or near theproximal end of the inserting component. The multiple-stent is attachedin a manner that leaves the distally facing apices 9800 unsewn, as shownin FIG. 98. Also shown here is the multiple-stent configuration. Byleaving the distally facing apices unsewn, they can fit into the pockets9610 created by folding the graft of the first component. In addition tousing the unsewn apices of stents to fit into the pockets 9610, anon-stent component can be added to the second component. Anotheralternative may include protruding features on the distal end of thestents. Some exemplary configurations of these features are shown inFIGS. 99 and 100. By having multiple filaments as depicted, it is morelikely that at least some of the filaments' apices will engage withpockets 9610 in the connecting component. The total number of filamentsis not critical, and a monofilament stent could also be sewn in the samemanner.

The configuration shown in FIG. 99 differs from the configuration shownin FIG. 98 by having the sewing performed on a larger percentage of theproximal struts (adjacent the proximal apices). The extra sewingincreases the security of the secure attachment to the stent graft ofthe engaging stent. Further, the distal apices 9900 are flared outwardfrom the wall of the stent graft. The flaring of the distal apices 9900is performed to increase the probability that some or all of the apicescatch into the pockets of the opposing component. Additionally, some,but not all, of the filaments of the multi-filament stent are cut. Thecutting of the filaments also creates additional independent catchpoints for the second component into the opposing first component. Theconcept behind cutting some (but not all) of the filaments is tomaintain some radial force in that segment. The configuration shown inFIG. 100 shows a cutting of all of the distal apices 10000. Thisconfiguration creates a maximum number of catch points for the pockets9610 (or other location). A trade off to this, as mentioned above, isthat there is no radial strength in that area of the stent. Theconfiguration of FIG. 100 only has a single apex cut. If desired, all ormore than one apex could be cut in this matter.

The configuration shown in FIG. 101 modifies the configuration of FIGS.98 to 100 by providing a partially sewn stent 10100 sewn right next to afully sewn stent 10110. Two benefits to this modification immediatelyarise. First, radial strength is increased. This helps keep both stentsagainst the lumen of the first component. Second, the configurationhelps prevent possible in-folding of the second component that couldblock the lumen of the entire device. This type of in-folding would bethe result of a poorly supported segment of the second component beingplaced under a significant axial load. If the distal apices or otherprotruding members have caught the pockets of the first component, thenthe top (proximal) apices could fold into the lumen. Another way toprevent this potential issue of in-folding due to an axial load could beto provide a fully supported stent proximal to the stent intended toengage with the first component.

The configuration shown in FIG. 102 illustrates non-stent components10200 used to engage the pockets 9610 (FIG. 96) of the first component.Here, a bio-compatible plastic or polymer is the shape of a closedladder with interior steps, any of the steps can be connected to thestent graft. As shown in FIG. 102, the upstream-most step is connectedto the cranial (upstream) stent at each of the upstream apices. Ofcourse, less than the number of such apices of the component 10200 canbe connected to non-stent component 10200. A desirable shape has thedistal end (downstream) curved outward to capture the pocket 9610 orvessel wall. One benefit of using a non-stent component 10200 is anon-metal reduces wear between adjacent components. These non-stentcomponents 10200 can be put at some or all of the apices of some or allof the stents, or between stents.

Another exemplary embodiment of devices that can be used to connect intothe pocket 9610 (FIG. 96) or the vessel wall is shown in the variationsof FIGS. 103 through 104. The stent 10300 with its downstream capturepegs 10310 can be used in the modular stent securement mechanismsdescribed herein. In this embodiment, the distally forcing pegs 10310 ofthe stent are flared out and are not sharpened. With this variation, thedistally facing pegs 10310 are not intended to penetrate through thefabric of the first component in which the pegs 10310 are to beconnected. In such a configuration, the distally facing pegs can end upin a pocket 9610 (FIG. 96) created in the first component.

In still another embodiment, and referring to FIGS. 78A and 78B, theinvention is a stent graft system 7809 comprising a first stent graft7820 that includes a first luminal graft component 7840 a plurality ofoutside stents extending along and fixed to an outside surface of thefirst luminal graft component 7840 and an inside stent 7860 between twooutside stents 7861, 7871, one of which is at a distal end 7880 of thefirst luminal graft component 7840 the inside stent 7860 fixed to aninside surface of the first luminal graft component 7840 and having aplurality of barbs 7863 pointed generally proximally within the firstluminal graft component 7840; and a second stent graft 7873 thatincludes a second luminal graft component 7874 and a plurality ofoutside stents 7875 extending along and fixed to an outside surface ofthe second luminal graft component 7873, whereby insertion of the secondstent graft 7873 into the distal end 7880 of the first luminal graftcomponent 7840 to overlap at least two stents of each of the first 7820and second stent grafts 7873 will cause interfering relation between atleast a portion of the barbs 7863 with a stent of the second luminalgraft component 7874 of the second stent graft 7873. Examples of maximumand minimum overlap of the first and second stent grafts are shown inFIGS. 79A and 79C.

The first luminal graft component 7840 of the stent graft system 7809can be bifurcated and the inside stent 7860 located in one of two legsof the first luminal graft component 7840.

The stent graft system of the invention can further include a pluralityof outside stents 7891 extending along and fixed to an outside surfaceof a second leg 7890 of the bifurcated first luminal graft, and a secondinside stent 7892 between two outside stents, one of which is at adistal end 7893 of the second leg 7890, the second inside stent 7892fixed to an inside surface of the second leg 7890 and having a pluralityof barbs 7894 pointed generally proximally within the second leg 7890.

A third stent graft 7895, shown in FIG. 79A includes a third luminalgraft component 7896 and a plurality of outside stents 7897 extendingalong and fixed to an outside surface of the third luminal graftcomponent 7896, whereby insertion of the third stent graft 7895 into thedistal end 7893 of the second leg 7890 to overlap at least two stents ofeach of the second leg 7890 and stent graft 7895 will cause interferingrelation between at least a portion of the barbs 7894 with a stent orthe third luminal graft component 7896 of the third stent graft 7895.

Stents of the stent graft system of the invention can be formed, atleast in part, of a superelastic metal, such as nitinol.

The variation shown in FIG. 105A is a stent 10500 with pegs 10510projecting downstream, not from the downstream apices 10520, but fromthe upstream apices 10530. In the variation shown in FIG. 106, the stent10600 has sharpened legs 10610 projecting from the downstream apices10620. Caudally facing barbs can be disposed on any number or all apicesof a leg stent. Sharpened barbs can penetrate the graft material of theprosthesis into which the graft is placed. In many cases, thisconfiguration would be a bifurcate, but could also be a previouslyplaced leg extension.

A further embodiment of the invention is a telescoping stent graftsystem, which is essentially identical to the stent graft system shownin FIGS. 79A and 79C, but lacks at least one set of barbs 7863 and 7894.In this alternative embodiment, the bifurcated first stent graftincludes a bifurcated first luminal graft component, a plurality ofoutside stents extending along and fixed to an outside surface of one oftwo legs of the bifurcated first luminal graft component. Optionally aninside stent extends between two outside stents, one of which is at adistal end of the first luminal graft component, the inside stent fixedto an inside surface of the first luminal graft component. A secondstent graft that includes a second luminal graft component and aplurality of outside stents extending along and fixed to an outsidesurface of the first luminal graft component, whereby the second stentgraft can be inserted into the distal end of a first of two legcomponents of the bifurcated first luminal graft component to overlap atleast two stents of each of the first and second stent grafts; aplurality of stents (e.g., outside stents and/or inside stents)extending along and fixed to an a surface (e.g., outside surface and/orinside surface) of a second leg of the bifurcated first luminal stentgraft. Optionally, a second inside stent is located between two outsidestents, one of which is at a distal end of the second leg, the secondinside stent fixed to an inside surface of the second leg. Also,optionally, a third stent graft is included having a third luminal graftcomponent and a plurality of outside stents extending along and fixed toan outside surface of the third luminal graft component, wherebyinsertion of the third stent graft can be inserted into the distal endof the second leg of the bifurcated first luminal graft component tooverlap at least two stents of each of the first and second stentgrafts. Regardless, the first leg is shorter than the second leg, andthe first leg includes at least one more stent than is required foroverlap of at least two stents of each of the second stent graft.

In an embodiment, one leg of the bifurcated stent graft of the inventioncan shorter in length (i.e., first or short leg) in the other leg (i.e.,second or long leg) of the bifurcated stent graft, as shown in FIGS.78A, 78B, 79A and 79C. When the bifurcated stent graft of the inventionis placed in the abdominal aorta, the long leg of the bifurcated stentgraft can be in the common iliac, as represented, for example, in FIG.72A, or in the aorta.

As shown in FIGS. 78A and 78B, the bifurcated first stent graft of thetelescoping stent graft system of the invention can include at least oneradiopaque marker 7800. In a particular embodiment, the shorter leg ofthe bifurcated first stent graft includes three lateral radiopaquemarkers 7801, 7802, 7803, one of which is at the distal opening of theshort leg, another of which is at the proximal end of the apex of aninside stent (i.e., second stent from the leg opening) and the third ofwhich is at the point of bifurcated on the first stent graft. Theradiopaque marker 7802 located at the apex of the inside stent candelineate the minimum (min) positioning of the third stent graft and theradiopaque marker 7803 can delineate the maximum (max) positioning ofthe third stent graft, as shown in reference to, for example, FIGS. 78A,78B, 127A, 127B, 127C and 127D. Two additional radiopaque markers 7804,7805 are distributed about the distal opening of the short leg.Radiopaque marker 7806 is located at a proximal end of an inside stentin the long leg of the bifurcated first stent graft.

The delivery systems, components of delivery systems, stents, grafts andstent graft systems of the invention can be employed in methods oftreating aortic aneurysms, such as abdominal aortic aneurysms.

In another embodiment, the invention is a method for treating anabdominal aortic aneurysm, comprising steps of directing a sheath anddistal tip of a delivery system to an abdominal aortic aneurysm of apatient through an artery, such as a femoral artery that cansubsequently pass through a common iliac artery, of the patient, thesheath containing a bifurcated stent graft; rotating a lead screw nut ofthe delivery system that is threadably linked to the sheath to therebyretract the sheath at least partially from the bifurcated stent graft;and sliding the lead screw nut along a handle body of the deliverydevice while the lead screw nut is threadably linked to the sheath tothereby further retract the sheath, whereby the bifurcated stent graftis at least partially deployed in the abdominal aortic aneurysm, therebytreating the abdominal aortic aneurysm.

The method of treating an abdominal aortic aneurysm can furtherincluding the step of opening a clasp at a distal end of the deliverydevice to release a bare stent at a proximal end of the bifurcated stentgraft. A portion of a first leg of the bifurcated stent graft can beretained within the sheath when the clasp is opened to release the barestent. The first leg of the bifurcated stent can be retained by fixing astent at a distal end of the first leg between the sheath and a legclasp. The first leg of the bifurcated is the longer of two legs of thebifurcated stent.

In another embodiment, the clasp employed in the method to treat anabdominal aortic aneurysm can distend struts of the proximal stenttoward a major axis of the delivery system when the sheath has beenretracted sufficient to expose the bare stent.

The method to treat an abdominal aortic aneurysm can further include thestep of cannulating a second leg of the bifurcated stent with anextension stent graft while the first leg is being held at leastpartially within the sheath. During cannulation, the leg that is beingheld is longer than the leg that is being cannulated and, optionally,the cannulated leg is in telescoping relation with the extension stentgraft. The cannulated leg can overlap the extension stent graft by atleast two stents of each of the cannulated leg and the extension stentgraft. The cannulated leg can include at least one more stent than isrequired to overlap the extension leg by two stents of each of thecannulated leg and the extension stent graft. A stent second from thedistal end of the cannulated leg can be within the graft of thebifurcated stent graft. The stent second from the distal end of thebifurcated graft can include barbs that extend inwardly and proximallyfrom the stent.

In another embodiment, the method of treating an abdominal aorticaneurysm can further include the steps of releasing the bifurcated stentgraft from the leg clasp, and then detaching a slider and the sheathfrom the remainder of the delivery device and withdrawing the remainderof the device from the patient while leaving the slider and sheathsubstantially in place and, optionally, further including the step ofdeliverying a second extension through sheath and to the first leg andcannulating the first leg with the second extension. The cannulatedsecond leg can overlap the extension stent graft by at least two stentsof each of the cannulated first leg and the second extension. Thecannulated first leg can include at least one more stent than isrequired to overlap the extension leg by two stents of each of thecannulated first leg and the second extension. A stent second from thedistal end of the cannulated first leg can be within the graft of thebifurcated stent graft. The stent second from the distal end of thebifurcated graft includes barbs that can extend inwardly and proximallyfrom the stent.

The methods of the invention have an advantage of repositioning of agraft (e.g., bifurcated graft, second stent graft, third stent graft)if, for example, a clinician determines initial positioning of the graftis less than optimal. The graft can be repositioned at its proximal anddistal end and proximally and distally in an aorta or branch of anaorta, such as a common iliac artery.

FIGS. 105A, 105B and 105C represent embodiments of a stent and use ofstent in a telescoping stent graft system of the invention.

FIGS. 107 to 109 illustrate various configurations for incorporatinghooks or barbs to Z-stents, in particular, bare stents, without usingthe material of the stent itself. FIG. 107 illustrates an exemplaryembodiment of a crimp hook 10700 according to the invention. A hook10710 is attached to or integral with a crimp sleeve 10720 that is tobecome part of a bare stent 10800 (bare spring) on an endoluminal stentgraft prosthesis. Many Z-stents are already connected at the two ends bya crimp sleeve to complete the circumference. The configuration addsactive fixation of the stent graft assembly, once deployed, into thesurrounding tissue of the vessel to prevent migration of the prosthesispost-deployment. To create the crimp hook 10700, for example, the hook10710 (which can be a pointed or sharpened wire if desired) can bewelded onto the body of the crimp sleeve 10720. The crimp hook 10700 is,then, attached to the ends of the bare stent 10800 by crimping (orwelding) it to the strut 10810. If multiple crimp hooks 10700 aredesired, the crimp hooks 10700 can be connected to individual stentportions 10820 defined by one apex 10830 and two halves of struts 10840,for example.

Alternative to the exemplary tubular structure shown in FIG. 107, thecrimp sleeve 10720 can be a clamshell that is placed over two adjacenthalves of a strut 10840 (or just a single, unbroken strut 10840) andcrimped thereon. After the bare stent 10800 is equipped with the crimphooks 10700, it can be affixed to the end of the stent graft 10900 asshown in FIG. 109. The crimp hooks 10700 in FIG. 109 are shown asrotated around the respective struts 10840 of the bare stent 10900 sothat they can be seen in the figure of this drawing. In use, however,the hooks 10710 will, for best apposition with the vessel wall, bepointed substantially radially outward from the longitudinal centralaxis of the stent graft.

In contrast to the bare stent crimp hooks above, FIGS. 110 and 111illustrate a crimp hook 11000 that is attached/affixed to the edge ofthe main body of the graft 11200, as shown in FIGS. 112 and 113. Withthe configuration shown, the crimp hook 11000 slides over the edge ofthe graft material (illustrated with a dashed line 11100) and iscompressed so that the two edges 11110, 11120 of the crimp pinch thegraft material 11100 therebetween to create a mechanical lock onto thegraft material 11010. This configuration adds active fixation of thestent graft assembly, once deployed, into the surrounding tissue of thevessel to prevent migration of the prosthesis post-deployment. Likeabove, the hook 11010 can be welded to the crimp body 11020, forexample, or can be integral therewith.

It is noted that providing barbs or hooks on the bare stent of the stentgraft (tube or bifurcated) increases the possibility of disadvantageouspuncture or scraping, whether to the outer sheath or to the interior ofthe vessel wall. In particular, with regard to the stent embodiments ofFIGS. 73 to 76, 79 to 85, and 103 to 106, for example, it would bedesirable to entirely prevent the possibility of inadvertent damage toeither the outer sheath or the vessel wall. To prevent such damage fromoccurring, the delivery system according to the invention employing barestents having such barbs is provided with a material umbrella 11400.

In one exemplary embodiment illustrated in FIG. 114, the umbrella 11400is attached (slideably or fixedly) to the lumen 11410 controlling theproximal apex capture portion 11420. When the stent graft 11500 iscollapsed and loaded within the outer sheath 11510, and is capturedwithin the proximal apex capture device 11420, 11520 (as shown in FIG.115), the bare stent 11530 spans the distance between the leading edgeof the graft and the apex capture device 11420, 11520. The umbrella11400 can be disposed outside the stent graft (and inside the outersheath 11510) but, in the exemplary embodiment shown in FIGS. 114 and115, the umbrella 11400 is held by the lumen 11410 interior to both theumbrella 11400 and the outer sheath 11510. Arms 11402 of the umbrella11400 extend therefrom between respective apices of the bare stent11530. The arms 11402 are relatively narrow at the intermediate portionwhere each is passing through the apices and expand to be relativelywide at their distal ends. In such a configuration, the distal ends ofeach arm 11402 can spread out over the adjacent bare stent apices and,if wide enough, overlap with adjacent other arms 11402 to canopy outaround the entire circumference of the exposed bare stent 11530 as shownin FIG. 115. At least one passage 11404 is formed at the distal portionof the arm 11402 so that a respective tine of the proximal apex captureportion 11420 can extend therethrough. In this configuration, the widedistal portions of the arms 11402 are controlled and stay against thebare stent, protecting the outer sheath 11510 and interior vessel wallup until the time when the apex capture device 11420, 11520 is actuated(a position that is shown in FIG. 115 but the bare stent 11530 and thearms 11402 have not yet been released from the tines of the proximalapex capture portion 11420). FIG. 116 is photograph depicting how theumbrella 11400 protects the interior of the vessel wall 11600 before thedelivery system has retracted the inner lumen 11410. As the inner lumen11410 is retracted, the umbrella 11400 will slide out from between thebare stent 11530 and the vessel wall 11600.

In an exemplary embodiment where infra-renal barbs of the stent graftare not desired, they can be moved higher on the bare stent so that theycan be covered by the fabric strips of the umbrella 11400.

FIGS. 117 to 124 illustrate a concept according to the invention thatuses a proximal clasp to expand the taper tip and create/improve a sealbetween the nose cone/tip and the outer sheath, the interfaceeliminating pronouncement of the outer sheath edge by taking up thespace between the tip and the outer sheath. The delivery systemsdescribed herein (e.g., AAA delivery systems), the concept of removingthe inner components of the delivery system (tip/support member) whileleaving the outer sheath behind requires the tip to be smaller than theID of the outer sheath. Due to the smaller shape of the tip, the problemof “fish mouthing” can occur at the tip-sheath interface. “Fishmouthing” occurs when the edge of the sheath becomes pronounced when thetip sheath interface is navigating the vessel, which could potentiallyscore the vessel wall, see FIGS. 117 and 118. To solve the problem thespace between the tip and the sheath needs to be eliminated but stillallow for removal of the tip. See FIGS. 119 to 120. To accomplish thisremoval of material underneath the distal claps and allowing theproximal clasp to be moved more forward so that the taper tip can beexpanded over the clasp taking lip the space between the sheath and tip.

FIGS. 125 and 126 illustrate an exemplary embodiment of a passiveproximal retainer 12500 for the AAA bifurcated stent graft according tothe invention, which retainer 12500 is referred to herein as a spokedhub. A proximal retainer is required for the ipsilateral leg of the AAAbifurcated stent graft. The proximal fixation holds the stent graft inthe deployment sheath during cannulation of the contralateral leg withthe guidewire and the leg stent. The passive proximal retainer device12500 is a hub fitted to the support member at the proximal end of thestent graft. The passive proximal retainer device 12500 has spokes 12502radiating out from a central hub 12504. The number of spokes isequivalent to the number of struts on the proximal end of the stent. Thespokes are engaged and trapped by the individual struts of the stentduring the loading process. The stent graft is loaded into thedeployment sheath through the use of a funnel. When the proximal end ofthe stent is just about in the deployment sheath, the support member isloaded next to the graft and the spokes of the hub are engaged in thegraft struts. The graft and support member are, then, pulled into thesheath. During deployment of the stent, the graft will not be releasedfrom the sheath until the sheath is fully retracted over the spoked hub.The outer diameter (OD) of the spokes are about 0.008 inches less thanthe inner diameter (ID) of the sheath, therefore, the stent struts aretrapped by the spoked hub until the sheath is retracted.

In one embodiment of the invention, hemostasis valve 12900, shown inFIGS. 129A-D, includes longitudinal valve housing 12902 defining slot12904 that extends transversely to major longitudinal axis 12906 ofvalve housing 12902. Longitudinal valve housing 12902 defines interiorsurface 12908 and has proximal end 12910 and distal end 12912. Gasket12914 defines interior conduit 12916 and has distal end 12918, whereindistal end 12918 is fixed relative to longitudinal valve housing 12902,and proximal end 12920 that is moveable relative to longitudinal valvehousing 12902. Gasket 12914 also includes collapsible intermediateportion 12922 between distal end 12918 and proximal end 12920. In oneembodiment, intermediate portion 12922 has a narrow internal diameterrelative to the remainder of interior conduit 12916 when gasket 12914 isfully open. On another embodiment, interior conduit 12916 of gasket12914 has an essentially constant diameter from distal end 12918 toproximal end 12920 of gasket 12914. Internal diameter of intermediateportion 12922 is further reduced by rotating at least one end relativeto the other end of gasket 12914 about major longitudinal axis 12906that extends through gasket 12914. Examples of suitable materials ofgasket 12914 include those that are known in the art, such as at leastone material selected from the group consisting of silicon, urethane,rubber and latex. In one preferred embodiment, gasket 12914 includessilicon. In one specific embodiment, gasket 12914 includes a coating ofsilicon. Grip assembly 12924 is located at proximal end 12910 oflongitudinal valve housing 12902. Grip assembly 12924 includes gripportion 12926 at first end 12910 of longitudinal valve housing 12902.Spindle portion 12928 of grip assembly 12924 is fixed to grip portion12926 by screw 12930 and extends from grip portion 12926 into interiorsurface 12908 of longitudinal valve housing 12902. As can be seen inFIG. 130, spindle portion 12928 is fixed to proximal end 12920 (FIG.129A) of gasket 12914 by proximal oetiker clamp 12932. Returning toFIGS. 129A-D, ratchet 12934 extends about spindle portion 12928 and isfixed to spindle portion 12920 by pin 12936, which also extends throughslot 12904 of longitudinal valve housing 12902. Ratchet 12934 definesteeth 12938 at an end of ratchet 12934 extending about spindle portion12928.

As can be seen in FIGS. 131A-C, longitudinal valve housing 12902includes lip 12940 at proximal end 12910 that defines distally-facingsurface 12942 at interior surface 12908. Spring, such as wave spring12944 extends about spindle portion 12928 and is located between gripportion 12926 at distally-facing surface 12942 and from ratchet 12934.In another embodiment, the spring is a compression spring.Alternatively, other suitable springs, such as are known in the art, maybe employed as alternatives to wave spring. Wave spring 12944 biasesratchet 12934 in a distal direction 12946 and relative to majorlongitudinal axis 12906 (FIGS. 129A, 129B).

Ratchet 12934 extends about spindle portion 12928 and is held in placebetween wave spring 12944 and interference element 12948, which, alsoextends about spindle portion 12928. Interference element 12948 is fixedto the longitudinal valve housing 12902 by screws 12950. Distal end12918 of gasket 12914 is fixed to main boss 12952 by distal oetikerclamp 12954. Main boss 12952 (FIGS. 129A, 129B) is fixed at the distalend 12912 of longitudinal valve housing 12902 by screw 12956.

In one embodiment, interference element 12948 includes at least one pin(not shown) that interfaces with teeth 12938 of ratchet. In anotherembodiment, interference element 12948 defines teeth 12958 thatinterface with teeth 12938 of ratchet 12934. Interference element 12948engages potentially a plurality of different positions relative toratchet 12934, each position thereby corresponding to a distinctposition of gasket 12914 between a fully opened position and a fullyclosed position. The position of gasket 12914, between a fully-open anda fully-closed position, is indicated by the position of pin 12936within slot 12904, as shown in FIGS. 131A-C. Gasket 12914 is conformableabout at least one catheter (not shown) extending through gasket 12914.

Rotation of grip portion 12926 causes rotation of spindle portion 12928and, consequently, rotation of proximal end 12920 of gasket 12914relative to distal end 12918 of gasket 12914, thereby closing gasket12914 when grip portion 12926 is rotated in one direction shown in FIG.131B, and opening gasket 12914 when grip portion 12926 is rotated in anopposite direction, shown in FIG. 131C. Interference between teeth 12958of interference element 12948 with teeth 12938 of ratchet 12934 causesgrip assembly 12924 and, consequently, gasket 12914, to remain inposition at potentially distinct positions of gasket 12914 in a fullyclosed position, a fully open position, and positions between fully openand fully closed. Interference element 12948 and ratchet 12934 remain inrespective relative positions when ratchet 12934 is not forced into adifferent rotational position relative to interference element 12948 byoperation of the surgeon. Wave spring 12944, forces teeth 12938 ofratchet 12934 against teeth 12938 of interference element 12948.

Referring to FIGS. 129A-129D, x-valves 12960, 12962 are stacked atdistal end 12913 within recessed portion 12964 of main boss 12952 andheld in place by spring pins 12966 and gasket spacer 12968. x-valves12960, 12962 each include at least one sealing component 12970, whereinsealing component 12970 defines at least one slot 12972. Support layer12998 of x-valve 12960 is at least partially embedded within sealingcomponent 12970. As shown, sealing component 12970 of x-valve 12960includes a plurality of slots 12972, 12978. Slots 12972, 12978 intersectwith each other. In one embodiment, slots 12972, 12978 intersect atdifferent angles. As shown, in FIG. 132A, slots 12972, 12978 intersectat the same angle. In another embodiment, shown in FIG. 132B, x-valve12961 includes a plurality of sealing layers 12980, 12982. In oneembodiment, each sealing layer includes at least one slot. As shown inFIG. 132B, slots 12984, 12986 of sealing layers 12980, 12982 aresubstantially aligned. In another embodiment, (not shown) slots 12980,12982 of sealing layers 12980, 12982 can be offset from each other.Respective intersecting slots of each sealing layer can be offset fromeach other by one-half of the angle of intersection of the slots of eachsealing component. Sealing components 12980, 12982 of each x-valve arepartitioned by support 12998. In a preferred embodiment, shown in FIG.132B, each sealing component 12980,12982 has a pair of slots 12984,12986 that intersect at right angles. Referring back to FIG. 129C, slots12972, 12990 of respective x-valves 12960, 12962, are offset from eachother by one-half of the angle of intersection of their respectiveslots. In alternative embodiments, not shown, slots 12974, 12978 ofrespective x-valves 12960, 12962 are aligned.

Typically, the sealing layers are formed of a suitable material, such asis known in the art. Examples of suitable sealing materials include atleast one member selected from the group consisting of silicon,urethane, rubber and latex.

As can be seen, support layer 12998 of x-valve 12960 includes peripheralring 12992 and plurality of arms 12994 extending from peripheral ring12992 to points proximate to the intersection of slots 12972. Support ofeach x-valve is formed of a suitable material, such as is known in theart. Examples of suitable materials of support layer 12998 includenitinol and titanium. In a preferred embodiment, support layer includesnitinol.

Wiper 12996 is held between gasket spacer 12968 and O-ring spacer 12999at distal end 12912 of hemostasis valve. Spring pins 13002 extendthrough O-ring spacer 12999, gasket spacer 12968 and main boss 12952,and server as assembly aids. Screws 13000 extend through O-ring spacer12999 and main boss 12952 and thread into longitudinal valve housing12902 to thereby hold O-ring spacer 12999, main boss 12952, and allintermediate components in place.

The teachings of all patents, published applications and referencescited herein are incorporated by reference in their entirety. Theteaching of U.S. Pat. Nos.: 7,763,063; 8,292,943; 8,308,790; 8,007,605;8,070,790; 8,062,349 and U.S. patent application Ser. Nos.: 11/699,700;11/700,609; 11/449,337; 11/701,867; 11/449,337; 11/701,876; 11/828,653;11/828,675; 12/137,592 and 12/723,431 are also incorporated by referenceherein in their entirety. While this invention has been particularlyshown and described with references to example embodiments thereof, itwill be understood by those skilled in the art that various changes inform and details may be made therein without departing from the scope ofthe invention encompassed by the appended claims.

What is claimed is:
 1. An x-valve, comprising: a) a valve housing; b) at least one sealing component within the valve housing, the sealing component defining a plurality of slots that intersect with each other; and c) a support layer that includes nitinol and partitions the sealing component, the support layer including a peripheral ring and a plurality of arms extending from the peripheral ring to points proximate to intersection of the plurality of slots, the plurality of arms embedded within the sealing component, whereby the x-valve can form a seal about a guidewire extending through the x-valve.
 2. The x-valve of claim 1, wherein the plurality of slots intersect at different angles.
 3. The x-valve of claim 1, wherein the plurality of slots all intersect at the same angle.
 4. The x-valve of claim 1, wherein the at least one sealing component includes a plurality of sealing layers, wherein the slots of the sealing layers are substantially aligned.
 5. The x-valve of claim 1, wherein the at least one sealing component includes a plurality of sealing layers, wherein the plurality of slots of the sealing layers are offset from each other.
 6. The x-valve of claim 1, wherein the at least one sealing component includes at least two sealing components abutting each other, each of which define at least one slot, and wherein the at least two sealing components are partitioned by the support layer.
 7. The x-valve of claim 6, wherein the intersecting slots of the respective sealing components are offset from each other.
 8. The x-valve of claim 7, wherein the respective intersecting slots are offset from each other by one half of the angle of intersection of the slots of each sealing component.
 9. The x-valve of claim 8, wherein each sealing component has a pair of slots that intersect at right angles.
 10. The x-valve of claim 1, wherein the sealing component includes at least one material selected from the group consisting of silicone, urethane, rubber and latex. 